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Clinical Trial Centers Alliance Presented October 2013 Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialcenters.com
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Independent (Non-SMO) entities in California, Texas and Florida comprise the Alliance Combined 500+ clinical trials conducted, phases I-IV Central IRB Large patient databases, affiliated medical practices and proven recruitment methods
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www.clinicaltrialcenters.com Alliance Facilities - C ALIFORNIA Pacific Research Partners, LLC San Francisco area, CA Inpatient and outpatient psychiatry (10 beds with flexible capacity) Collaborative Neuroscience Network, LLC Long Beach, CA 25,000 sq ft dedicated research facility Clinical Pharmacology Unit – 60+ bed phase I unit for healthy subjects, and CNS, general medical, bioequivalence and ethno-bridging patient populations Psychiatric Health Facility – separate 20 bed, private rooms, licensed psychiatric health care unit for inpatient psychiatric populations Inpatient and outpatient neurology and general medical patient populations Garden Grove, and Torrance, CA Outpatient psychiatry
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www.clinicaltrialcenters.com Alliance Facilities - T EXAS FutureSearch Trials, LP Austin, TX Inpatient and outpatient psychiatry (30 beds) including phase I special populations Inpatient and outpatient sleep disorders (6 bed sleep lab for PSG studies)6 bed sleep lab Outpatient general medical, neurology and pain disorders Dallas, TX Inpatient and outpatient psychiatry (10 beds with flex capacity) Outpatient Alzheimer's disease, cognitive dysfunction, pain, and insomnia disorders
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www.clinicaltrialcenters.com Alliance Facilities - F LORIDA Outpatient Alzheimer’s, cognitive dysfunction, MCI, general medicine, and pain disorders Florida Clinical Research Center, LLC Bradenton, FL Inpatient and outpatient psychiatry, pediatric - adult (10 beds with flexible capacity) Outpatient general medicine and pain disorders Maitland, FL Inpatient and outpatient psychiatry, pediatric – adult (30 beds with flex capacity)
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David Walling, PhD Armen Goenjian, MD Donald Garcia, MD Omid Omidvar, MD Mark Leibowitz, MD Michael Downing, MD Ira Glick, MD Steven Reynolds, DO Nirav Patel, MD John D. Hudson, MD CALIFORNIA TEXAS FLORIDA Andrew Cutler, MD Richard Knapp, DO Joanne Northcutt, PhD Jose Zaglul, MD
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www.clinicaltrialcenters.com Curriculum Vitae Click on names to view CVs: David P. Walling, Ph.D. David P. Walling, Ph.D. CEO and PI – CNS Network, LLC Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS Network, LLC Omid Omidvar, M.D. Omid Omidvar, M.D. PI – CNS Network, LLC Nirav S. Patel, M.D. Nirav S. Patel, M.D. PI – CNS Network, LLC Steven Reynolds, D.O.Steven Reynolds, D.O. PI – CNS Network, LLC Mark Leibowitz, M.D.Mark Leibowitz, M.D. – PI – CNS Network, LLC Ira D. Glick, M.D. Ira D. Glick, M.D. PI – Pacific Research Partners, LLC Donald J. Garcia, M.D. Donald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LP John Douglas Hudson, M.D. John Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LP Michael Downing, M.D. Michael Downing, M.D. PI– FutureSearch Trials of Dallas, LP Andrew J. Cutler, M.D. Andrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLC Jose T. Zaglul, M.DJose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLC Richard D. Knapp, D.O. Richard D. Knapp, D.O. PI – Florida Clinical Research Center, LLC Joanne Northcutt, Ph.D.Joanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLC
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www.clinicaltrialcenters.com Site Highlights Fulltime Dedicated and Highly Experienced Staff Investigators Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, and Licensed Clinical Psychologists Protocol consultants to sponsors and CROs in psychiatry, neurology and sleep indications Fulltime certified psychometric and clinical raters – M.D., Ph.D. and M.A.-level with 3-10+ years rating experience Multiple fulltime study coordinators including CCRCs, RNs, and LVNs Dedicated recruitment specialists with established referral networks in their communities Regulatory, QA, training and IT personnel
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www.clinicaltrialcenters.com Specialized Capabilities and Experience Dedicated 25,000 sq ft Clinical Pharmacology Unit in Long Beach, CA Cardiac telemetry and holter monitoring QTc and TQT EEG and qEEG Evoked potentials Extensive PK sampling Imaging: 3T MRI Scanner capable of 3.0 Tesla fMRI procedures 64-Slice PET/CT system Lumbar puncture and CSF collection PSG (polysomnography) IV infusion, oral, device, and transdermal patch delivery systems
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www.clinicaltrialcenters.com Phase I-IV Trial Experience Psychiatry Addictions – smoking cessation, alcohol dependence, and binge eating ADHD – adult and child, including classroom ADHD studies Anxiety – GAD, PTSD Bipolar – bipolar depression, mania, mixed Cognition – in schizophrenia, mild cognitive impairment Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction Schizophrenia and schizoaffective disorders – acute, cognition, negative symptoms, stable Pediatric psychiatry Neurology Alzheimer’s – MCI, mild-to-moderate, prodromal, and severe Pain – chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia Parkinson’s – early stage to advanced Post-stroke Multiple Sclerosis – relapsing remitting Sleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea General Medical COPD, asthma, hypercholesterolemia, hypertension, obesity, type 2 diabetes, women’s health
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www.clinicaltrialcenters.com Recruitment and Retention Recruitment Full time dedicated recruitment and outreach specialists on staff Large site databases accumulated over 13+ years of research across all indications Affiliated PI physician practice databases Established relationships with network of physicians for additional patient referrals Outreach to and established relationships with residential facilities, board and cares, senior communities Participation in community events and support groups – outreach specialists provide free seminars, lunch and learns, distribute flyers and posters History of successful print, web, radio, and television advertising – recruitment departments have established relationships with media buyers for discounted advertising rates and placement Ability to pre-qualify patients via IRB-approved pre-screen consent form Retention Inpatient facilities have private rooms, double occupancy for caregivers or loved ones as needed Site-provided patient transportation as needed Fulltime dedicated staff for regular contact with patient and family Reminder and follow-up phone calls Many of the study patients are treated in the PIs and Sub-Is practices allowing for ease in transition, follow up and retention
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www.clinicaltrialcenters.com Affiliated Practices Affiliated Medical Practices Collaborative Neuroscience Network is aligned with largest psychiatry, neurology and family group practices in the LA and Orange County regions. Pacific Research Partners has exclusive relationship with largest mental health clinics in the San Francisco Bay Area. FutureSearch Trials in Austin is aligned with Neurologist/Sleep Medicine PI, Dr. Hudson’s large sleep medicine practice and sleep lab on premises of research facility. FutureSearch Trials in Dallas aligned with Dr. Downing‘s psychiatric practice. Both Austin and Dallas have community referral relationships with residential facilities and mental health agencies. Florida Clinical Research Center is aligned with Child Psychiatrist PI, Dr. Jose Zaglul. Child and Adult Psychiatrist Jose T. Zaglul, MD has joined Florida Clinical Research Center in a fulltime capacity while continuing to maintain his professional relationship with a large community mental health system in Bradenton, FL where he has been Chief Medical Officer for many years. He is now Medical Director for Florida Clinical Research Center and the primary PI for all inpatient studies and several outpatient studies.
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www.clinicaltrialcenters.com Alliance Advantages and Expertise Central IRB Responsiveness and ease of single point of contact with site relations team for rapid turnaround on site selection coordination and communications Dedicated regulatory and budget and contract staff for quick turnaround times Collaborative relationship with many CROs, including partnerships for monitoring and data management capabilities, if requested Share best clinical and operational practices across sites Site-based internal training programs Publications and advisory board memberships Clinical feedback and protocol consulting during development process, if needed Affiliation with full-service, boutique CRO for any combination of the following: protocol writing, data management, statistical analysis, vendor coordination, monitoring, general study management - can be utilized for stand-alone services or as sub-contractor to clinical trial site
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www.clinicaltrialcenters.com Preferred Relationships with Sponsors and CROs Protocol review Pre-feasibility assessment Budget estimates Master agreements in place Rapid start-up and first-patient-in
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Rating Scale Experience: ACDS ACR ADAS-COG ADCS-ADL ADCS-CGI ADFACS ADR ADMACQ AIMS AISRS/ADHD RS-IV ASEX BACS BAI BARS BAS BDI BPI-SF BPRS BSS BVMT CAADID CAARS CAI CANTAB CADSS CBQ CCT CDIS CDR/CDR-SOB CDRS-R CDSS CF CGDS CGI-BP/I/S/SCA-S CIBIC CIBIS-plus COG STATE COWS CPRS CPT CRTT CSDD C-SSRS DAD DCSQ DESS DS DSIS DSM-IV Diagnosis DSST EQ-5D 5L and 3L proxy ESRS ESS FAQ FAST FCSRT-IR FIQ FMS FOSQ FTND GAF GAS GBI GDS Go/ No Go Task HAM-A HAM-D HIS Hoehn & Yahr HRUQ HUI HVLT IADCQ ISI KBIT K-SADS LSEQ MADRS MATRICS MCCB (Matrics) MGH ATRQ MINI mMIDI MMSE MNSI Part b MoCA MOS MOS-SS MSLT NAB NC070 NDS NDT NINCDS NPI NPS NRS NSA NTB NTSS-6 NYPRS PAC-QoL PANSS PDQ PGA PINRS POMS PPSQA PQAS P-R CSA PSP PSQI PUTS PWI PWC QIDS-16 QL21, QL 98 Q-LES-Q QOL QOL-AD RAVLT RSQ – D/W RUD-Lite RUSP RUQ SANS SAS SASS SBQ-R SCID SCL-90 SCOPA SCoRS SDS SIB SIGH-D SLOF SOWS SQLM SRTT STS SWN TMTP 1, 2 Trails TSQM TSSR UPDRS VAS WCST WMS WOMAC WPAI WRAADS WTAR UPSA YBOCS YGTSS YMRS Certified, experienced raters, including M.D., Ph.D. and M.A.-level
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www.clinicaltrialcenters.com Phase I Special Populations Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase I, prospective, randomized, double-blind, placebo- controlled, sequential-cohort, escalating, single-dose study designed to determine the maximum tolerated oral dose of XXX in healthy, male volunteers 54272 months2013Active A Phase Ib, Randomized, Double-Blind, Placebo-Controlled, Sponsor-Open, Study to Examine the Safety, Tolerability and Pharmacokinetics of XXX in Psychiatrically Stable Subjects with Schizophrenia 46303 months2012Closed A Phase I, Open-Label, Single Group, Multiple-Dose, Study to Evaluate the Pharmacokinetics of XXX Drug Delivery System following 24-hr Application in Patients Diagnosed with Parkinson’s Disease 18124 months2012Closed A Phase I, 2-part, Open Label, Inpatient Study to Assess the Safety and Tolerability of Multiple Ascending Doses of XXX in Subjects with Schizophrenia (Extensive PKs & multiple ECGs) 62408 months2012Closed Phase I, Inpatient Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of XXX in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period 5420 (SFs due to pts not having a migraine in req’d window) 8 months2012 TOP ENROLLING SITE A Phase I, Inpatient Multicenter, Open-Label Study to Determine the Effects of XXX on Sleep in Healthy Subjects 26135 months2012 TOP ENROLLING SITE
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www.clinicaltrialcenters.com Phase I Special Populations Sample Metrics ( cont’d ) Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase I, Parallel-Group, Double-Blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of XXX on QT/QTc in Subjects with Schizophrenia or Schizoaffective Disorder 34251 month2012Closed A Phase I, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects (Extensive PKs & multiple ECGs) 38226 weeks (across 2 sites) 2011TOP ENROLLING SITE A Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of XXX in Subjects With Mild to Moderate Alzheimer’s Disease Study design 5 cohorts; 1 pt/cohort from ea site 101-2 months depending on cohort 2011TOP ENROLLING SITE A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multiple, Escalating Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of XXX in Elderly Volunteers and in Subjects With Mild Alzheimer's Disease (included Lumbar Puncture and PET) 1172 months2011RESCUE SITE A Phase I, Effect of XXX on Ambulatory Heart Rate and Blood Pressure in Patients with Major Depressive Disorder who are being Treated with Selective Serotonin Reuptake Inhibitors 12 6 weeks2011Closed
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www.clinicaltrialcenters.com Phase IIa Special Populations Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase IIa Randomized, Double-Blind, Cross over Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX 11101 month2010RESCUE SITE A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety, and Efficacy of a Single Dose of XXX in Adults with Attention Deficit Hyperactivity Disorder (ADHD) 17143 months2010Closed A Phase IIa, Multicenter, Double-Blind, Randomized, Parallel Group, 4-week Inpatient Treatment Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Two Fixed Doses of XXX Compared to Placebo, Using XXX as an Active Control, in the Treatment of Acute Exacerbation of Schizophrenia 57415 months2010Closed A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of XXX for Migraine Prophylaxis in Patients with Episodic Migraine 23156 weeks2008Closed A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses for XXX in Patients with Schizophrenia 134986 months2008Closed A Phase IIa Placebo- and Positive-Controlled, Randomized Study, Evaluating QT and QTc Intervals following Administration of Immediate-Release of an Atypical Antipsychotic in Subjects with Schizophrenia or Schizoaffective Disorder 18151 month (across 2 sites) 2007Closed
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www.clinicaltrialcenters.com ADHD Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase III, Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of XXX in Pediatric Patients with Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom 17153 months2012Closed A Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed-dose, Study to Assess Efficacy, Safety and Tolerability of XXX in Adults with Inattentive-Predominant Attention Deficit/ Hyperactivity Disorder (ADHD) 32275 months2012Closed A Phase II, 40-week, Randomized, Double-Blind, Placebo- Controlled, Multicenter Efficacy and Safety Study of XXX in the Treatment of Adult Patients with Childhood-onset ADHD 22195 months2011Closed A Phase III, Parallel, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Forced Dose Study to Evaluate the Safety and Efficacy of XXX Extended Release Capsules in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Pediatric and Adolescent Patients Aged 6 up to 18 years 15132 months2011Closed A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center, Fixed Dose Titration Study to Assess Efficacy, Safety, and Tolerability of XXX in Adults with Attention Deficit/Hyperactivity Disease (ADHD) 48364 months (across 2 sites) 2010Closed
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www.clinicaltrialcenters.com ADHD Sample Metrics ( cont’d ) Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase III, Double-Blind, Randomized, Multicenter, Placebo Controlled, Dose Optimization Study Evaluating the Tolerability and Efficacy of AM and PM Once Daily Dosing with Extended-Release XXX in Children Aged 6-12 with Attention-Deficit/Hyperactivity Disorder 14124 months2010Closed A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose Optimization Study Evaluating the Efficacy and Safety of XXX in Combination with Psychostimulants in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder 37299 months (across 2 sites) 2009Closed A Phase IV, Placebo-controlled, Double-blind, Parallel- group, Individualized Dosing Study Optimizing Treatment of Adults with Attention-Deficit/Hyperactivity Disorder to an Effective Response with XXX 16122 months2009Closed A Phase IV, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, 3x3 Cross-Over Study Demonstrating Superior Efficacy of XXX Versus XXX in children, Aged 6-12 Years, with Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting 19181 month2008Closed
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www.clinicaltrialcenters.com Alzheimer’s Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase II Long-Term Efficacy Response Trial: The planned trial will be a six month, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of daily administration of XXX in subjects with Mild to Moderate Alzheimer’s Disease 765 months2013Active A Phase III, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of XXX for the Treatment of Mild to Moderate Alzheimer’s Disease (includes IGIV, and infusion) 151014 months2013TOP ENROLLING SITE A Phase III, Randomized Controlled Trial to Assess the Efficacy of a Medical Food in Patients with Mild to Moderate Alzheimer’s Disease using Alzheimer’s Disease Medication 191516 months2010Closed A Multicenter, Randomized Double-Blind Placebo- Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of XXX in the Treatment of Patients with Mild to Moderate Alzheimer's Disease 21117 months2009Closed
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www.clinicaltrialcenters.com Anxiety Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder 18106 months (across 2 sites) 2013Active A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study of 2 Oral Dose Groups of XXX, with a XXX Arm, in Subjects with Generalized Anxiety Disorder 1494 months2009Closed A Randomized, Double-Blind, Parallel-Group, Placebo- Controlled, Fixed-Dose Study Comparing the Efficacy and Safety of a Single Dose of XXX in Acute Treatment of Adults With Generalized Anxiety Disorder 15105 months2008Closed A Phase III, Randomized Double-Blind, Parallel Group 10- week Placebo-Controlled Fixed Dose Study of XXX and XXX Evaluating the Efficacy and Safety of XXX for the Treatment of Generalized Anxiety Disorder 29227 months2008Closed A Phase II, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Exploratory Study to Evaluate the Effect of XXX on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder 1384 months2008Closed
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www.clinicaltrialcenters.com Bipolar Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase III, 24-Week, Flexible-Dose, Open-Label Extension Study of XXX for the Treatment of Bipolar I Depression 11 7 months2011Closed A Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder 23169 months2011TOP ENROLLING SITE A Multi-Center, Randomized, Parallel-Group, Double-Blind, Phase IV Comparison of the Efficacy and Safety of XXX (oral tablets daily in divided doses) to Placebo as Adjunct Therapy to Mood Stabilizers (XXX or XXX) in the Treatment of Bipolar I Disorder and Alcohol Dependence in Adult Patient Receiving Treatment for 12 Weeks 31219 months2006Closed A Multicenter, Randomized, Double-Blind, Placebo Controlled Study of XXX Monotherapy in the Treatment of Acutely Manic Patients with Bipolar I Disorder 17132 months2006Closed
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www.clinicaltrialcenters.com Depression Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed Dose Study on the Efficacy of XXX on Cognitive Dysfunction in Adult Patients with Major Depressive Disorder 983 months2012Closed A Phase II, Multicenter, Randomized, Double-Blind, Active- Controlled Study of the Efficacy and Safety of Flexibly-Dosed XXX in Patients with Treatment Resistant Major Depression 311712 months2012Closed A Phase III, Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Relapse Prevention Study with XXX in Out-Patient Adults with Major Depressive Disorder 32243 months2010Closed A Phase IV, Randomized, Double-Blind, Parallel Group Study to Compare Discontinuation Symptoms in Abrupt Discontinuation Versus a 1-Week Tapering Regimen in Subjects with Major Depressive Disorder Treated for 24 Weeks with Open-Label XXX 22183 months2010Closed A Phase IV, Multi-center, Double-Blind, Randomized, Placebo- Controlled Study to Evaluate Functional Outcome in Outpatients with Major Depressive Disorder treated with XXX 16122 months2009Closed
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www.clinicaltrialcenters.com Pain Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase III, Randomized, Double-blind, Placebo-Controlled, Multicenter Trial with an Enriched Study Design to Assess the Efficacy and Safety of XXX Controlled-Release Tablets Compared to Placebo in Opioid-Experienced Subjects with Moderate to Severe Pain due to Chronic Low Back Pain who Require Around-the-clock Opioid Therapy 231510 months2012Closed A Phase III, Open-Label, Multicenter Study to Assess the Long -Term Safety of XXX Once-Daily in Subjects with Moderate to Severe Chronic Nonmalignant and Nonneuropathic Pain 22203 months2012Closed Phase IIb, Double Blind, Randomized, Placebo Controlled, Dose-Ranging Trial of XXX for the Acute Treatment of Migraine 30263 months2012Closed A Phase III, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with Fibromyalgia (13-week single and double blind phases, outpatient study including Actigraphy, PK, Multiple Psychiatric, Sleep & Pain Assessments, and Diary) 49337 months2011TOP ENROLLING SITE A Phase III, Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of XXX and XXX Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain 28243 months2011TOP ENROLLING SITE
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www.clinicaltrialcenters.com Pain Sample Metrics ( cont’d ) Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase IIb, 12-Week, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of XXX in Subjects with Moderate to Severe Chronic Low Back Pain 27234 months2011Closed A Phase III, Safety and Tolerability Study Comparing XXX Given as an Oral Solution to a Single-blinded Combination of Oral Tablets plus Oral Solution in Subjects with Fibromyalgia 14122 months2010Closed A Six Month Phase II/III, Randomized, Double-Blind, Placebo- Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of XXX for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine 42413 months (across 2 sites) 2010Closed A Phase IIa, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of XXX for Migraine Prophylaxis in Patients With Episodic Migraine 23156 weeks2009Closed The Analgesic Efficacy And The Safety Of XXX And Placebo In Approximately 275 Subjects With Diabetic Neuropathic Pain 22184 months2008Closed A Phase III Study of the Chronic Intermittent use of XXX and XXX in the Acute Treatment of Migraine Attacks With or Without Aura in Adults to Evaluate the Effect on Blood Pressure 1072 months2008Closed
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www.clinicaltrialcenters.com Cognition in Schizophrenia and Schizophrenia Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase II, 12 Week Randomized, Double-blind, Placebo-controlled, Parallel Group, Multiple Dose, Proof-of-Concept Study to Evaluate the Effects of XXX on Cognition in Stable Schizophrenia Patients 664110 month ( across 2 sites ) 2013Active A Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX IM Depot Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia 40281 month2013Closed A 12-week, Phase III, Multicenter, Randomized, Double-blind, Placebo- controlled Trial of XXX IM Depot in the Acute Treatment of Adults With Schizophrenia 23217 months2013Closed A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of XXX versus Placebo in Patients with DSM-IV-TR Schizophrenia 503915 months2012Closed A Phase II, Double Blind, Placebo Controlled, Multi-Center, Parallel Group Study to Assess Efficacy, Safety and Tolerability of XXX as Augmentation Therapy to Improve Cognition in Outpatients with Cognitive Dysfunction in Schizophrenia 19112 months2011Closed A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Study of the Safety and Efficacy of XXX in the Treatment of Cognitive Deficits in Schizophrenia (CDS) 221710 months2011Closed A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of Oral Doses of XXX and Placebo on Top of an Established Treatment Regimen of XXX Monotherapy in the Treatment of Cognitive Impairment in Schizophrenia 685021 months2008Closed
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www.clinicaltrialcenters.com Sleep and RLS Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase IIIb, Double-blind, Randomized, Placebo-controlled Study of XXX and its Effect on All-day Functioning and Quality of Life in Subjects with Moderate to Severe Idiopathic Restless Legs Syndrome 36255 months2012TOP ENROLLING SITE Device Study: Evaluation of an All-in-One Positive Airway Pressure System 10 1 month2011Closed A Phase II Randomized, Double-blind, Placebo-and Active- Comparator-Controlled Study of the Safety and Efficacy of XXX in Outpatients with Insomnia 28214 months2009Closed A Phase II, Randomized, Double-blind, Placebo-controlled, Multi- center Crossover Study of XXX as a Daily Treatment for Excessive Daytime Sleepiness (EDS) associated with Narcolepsy 14116 months2009Closed A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of XXX in the treatment of Primary Insomnia 15101 month2007Closed A One-Year Open-label, Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of XXX Treatment in Children and Adolescents with Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome 651 month2006Closed
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www.clinicaltrialcenters.com Additional Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of EnrollmentYearStatus A Phase IV 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of XXX Fixed Dose Combination Versus XXX Monotherapy in Adolescents and Adults With Persistent Asthma 161413 months 2013Active An Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of XXX 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily Subcutaneous Injections in Subjects with Relapsing-Remitting Multiple Sclerosis 762 weeks2013Active A Phase III, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder 36214 months (across 2 sites) 2013Closed Pilot Epilepsy Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data 556 months2013Closed A Phase IV, Multi-national, Randomized, Double-blind, Placebo- controlled, Study to Evaluate the Efficacy and Safety of XXX Compared to Placebo for Smoking Cessation Through Reduction 58452 months2011Closed A Phase II, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, Adaptive Study of the Safety and Efficacy of XXX in Adults with Alcohol Dependence 22164 months2010Closed
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www.clinicaltrialcenters.com Placebo Response Data - ADHD
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www.clinicaltrialcenters.com Placebo Response Data - ADHD
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www.clinicaltrialcenters.com Placebo Response Data - ADHD
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www.clinicaltrialcenters.com Placebo Response Data - ADHD
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www.clinicaltrialcenters.com Placebo Response Data - Bipolar
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www.clinicaltrialcenters.com Placebo Response Data - GAD
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www.clinicaltrialcenters.com Placebo Response Data - MDD
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www.clinicaltrialcenters.com Placebo Response Data - MDD
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www.clinicaltrialcenters.com Placebo Response Data - MDD
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www.clinicaltrialcenters.com Placebo Response Data - MDD
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www.clinicaltrialcenters.com Placebo Response Data - Schizophrenia
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www.clinicaltrialcenters.com Placebo Response Data - Schizophrenia
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www.clinicaltrialcenters.com Placebo Response Data - Schizophrenia
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www.clinicaltrialcenters.com Placebo Response Data - Schizophrenia
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www.clinicaltrialcenters.com Placebo Response Data - Schizophrenia
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www.clinicaltrialcenters.com Database #s By Indication Indication CNSN LA/Orange County PRP Oakland/ San Francisco FST Austin FST Dallas FCRC Maitland FCRC Bradenton Psychiatry Addiction 800 1,000600 Access to alcohol, smoking, binge eating Bipolar 1,600Treats 50/mth1,000 2,200 Depression (incl. TRD) 2,500 Treats 100/mth 2,000 1,1502,500 Post Traumatic Stress Disorder & Panic 200n/a350200150120 Schizophrenia 2,900 Treats 500+/mth 10005001502,000 ADHD – adultn/a2002,5004001,0001,500
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www.clinicaltrialcenters.com Database #s By Indication ( cont’d ) Indication CNSN LA/Orange County PRP Oakland/ San Francisco FST Austin FST Dallas FCRC Maitland FCRC Bradenton Neurology Alzheimer’s1,25050 30080n/a Alzheimer’s – Mild Cognitive Impairment 1755050/mth500100n/a Epilepsy – Mild to Severe Seizures 850n/a350n/a Multiple Sclerosis245n/a70n/a Parkinson’s900n/a110n/a Stroke900n/a175n/a Traumatic Brain Injury275n/a200n/a
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www.clinicaltrialcenters.com Indication CNSN LA/Orange County PRP Oakland/ San Francisco FST Austin FST Dallas FCRC Maitland FCRC Bradenton Pain Chronic (back/knee/hip)1,475n/a2,0001,00050 DPN/Neuropathy (diabetic, non- diabetic, polyneuropathy) & PHN 1,200n/a1,25010050n/a Fibromyalgia4001001,5001,700250 Osteoarthritis (general incl knee and hip) 300n/a90050100200 Migraine500Future indication1,10050020080 Opioid Induced Constipation150Future indication100 n/a Rheumatoid Arthritis175n/a260n/a Sleep Disorders Adult Insomnia n/aFuture indication1,7501003001571 Elderly Insomnia n/a 75010015025 Restless Legs Syndrome400n/a1,800100n/a Database #s By Indication ( cont’d )
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www.clinicaltrialcenters.com Database #s By Indication ( cont’d ) Indication CNSN LA/Orange County PRP Oakland/ San Francisco FST Austin FST Dallas FCRC Maitland FCRC Bradenton General Medicaln/a Acid Reflux1,000n/a 200 Constipation130n/a 300 COPD/ Asthma200 n/a100150 Diabetes2,100500250500 High Cholesterol1,100500250700500 Hypertension/ Hyperlipidemia 1,0501,000100600400 Irritable Bowel Syndrome/Disorder 150100n/a50400 Men’s/Women’s Health1,350250n/a5001,200 Obesity1,350100 7401,000
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www.clinicaltrialcenters.com Sponsor Relations Team Jeanette Caruso Finance Manager Bobbie Theodore Alliance Director clinicaltrials@btheodore.com (866) 669-0234 Annie Speno Operations Manager Expedited feasibility and budget/contract negotiation handled by single point of contact with Sponsor Relations Team. Our team is responsible for handling the business development needs of the group, sponsor and CRO relations, facilitating the site selection process (CDAs, feasibility questionnaires, CVs, site capabilities information), budgets and contracts, keeping in regular contact for feedback and garnering new study opportunities so the site personnel can focus on their studies in process. There is no charge to sponsors or CROs for these services.
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