1. CSNA Clinical Trials
NEUROLOGY

2. Principal and Sub-Investigators
Dr. Adams
Dr. Komatineni
Christen Kutz, PA-C
Dr. Scott
Dr. Wagner
Deanna Johnson, PA-C
Beth Harmon, PA-C
Linnea Hughes, PA-C
Dr. Bjork

3. BEL115123-PI Dr. Adams Myasthenia Gravis
‘A Randomized, Placebo-Controlled, Double-Blind, Multinational Study of Belimumab (10 mg/kg) To Investigate The Efficacy And Safety of Belimumab In Subjects With MG.
Sub-Investigators, QMG raters-Dr. Komatineni, PA Kutz. Pharmacist, Dorothy Hicks, RN
Sponsor: GSK
Study Drug: Belimumab
Currently we have 2 subjects who have completed the study and 2 screen failures.
Enrolling until November 21, 2014
Primary Inclusion Criteria:
Diagnosis of Myasthenia Gravis class II to IV inclusive
AChR or MuSK antibody positive
Stable dose of Cholinesterase for at least 2 weeks prior to screening (PTS)
Male or Female (of non-childbearing potential)
18 years or older with life expectancy of at least 1 year

4. Presence of previous history of thymoma
Thymectomy Primary Exclusion Criteria
within 12 months
Have received IVIg and or plasmapheresis within 4 weeks prior to screening
Have received treatment with rituximab within 12 months prior to screening or treatment with belimumab (or any other B cell targeted therapy at ANY time)
Have received cyclophosphamide or any other immunosuppressive agent within the past 6 months.

5. EXPAND (BAF)-PI Dr. Komatineni SPMS
‘A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis.’
Sub-Investigators: EDSS Rater, Dr. Adams. First Dose Administrators, Dr. Scott, Dr. Wagner. MSFC administrator, Nikki Fraley
Sub-Contractors, Colorado Springs Imaging, Colorado Springs Pulmonary Consultants, Colorado Springs Dermatology, Eye Associates of Colorado Springs
Sponsor: Novartis Study Drug-Siponimod
Currently we have 1 subject enrolled, 2 screen failures
Enrolling through March, 2015
Primary Inclusion Criteria
Prior history of relapsing-remitting MS
Secondary progressive course of MS defined by a progressive increase of disability in the absence of relapses or independent of relapses
EDSS of at screening

6. No evidence of relapse or corticosteroid treatment within 3 months prior to randomization
Primary Exclusion Criteria
Patients with active chronic disease
Treated with certain DMTs
History of cardiovascular conditions
History of pulmonary conditions
Unable to undergo MRI scans

7. Adhere-PI Christen Kutz Multiple Sclerosis
‘A multicenter, open-label phase IV study to evaluate whether a Medication Event Monitoring System (MEMS) can improve adherence to Tecfidera (delayed-release dimethyl fumarate) treamtment in Multiple Sclerosis Patients.’
Biogen Sponsored
Sub-Investigator, Dr. Adams
Study Drug-Tecfidera
Not yet enrolling
Primary Inclusion Criteria
Decision to treat with DMF must PRECEDE a decision to evaluate the patient for participation in the study.
Candidate is a DMF-Naïve patient
Have a diagnosis of relapsing forms of MS and satisfy the approved therapeutic indication for DMF
Primary Exclusion Criteria
Receiving concomitant disease modifying therapies for relapsing forms of MS.
Are participating, planning to participate or have participated in the Tecfidera Quickstart Program.

8. REVEAL-PI Dr. Adams Multiple Sclerosis
‘A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects’
Sub-Investigators: EDSS Rater, Beth Harmon, PA-c, Deanna Johnson, PA-c. Pharmacist, Dorothy Hicks, RN.
Sub-Contractors, Colorado Springs Imaging, Colorado Springs Pulmonary Consultants, Colorado Springs Dermatology, Eye Associates of Colorado Springs
Biogen sponsored, randomized, open-label
Study Drug-Gilenya and Natalizumab
Ready to enroll
Primary Inclusion Criteria
Documented diagnosis of relapsing MS
If on BRACE at screening, must have beenon therapy for at least 12 months AND experienced ≥ 1 relapse with in the last 6 months PRIOR to screening with ≥ 1 new T1-Gd=lesion or ≥ 2 new T2 lesions on a brain MRI scan performed ≤ months prior to screening…
DMT naïve at screening with ≥ 2 relapses in the 12 months prior to study screening with ≥ 1 new T1-Gd+lesion or ≥ new T2 lesions on MRI performed ≤6 months prior to screening.
EDSS score from inclusive at screening

9. Exclusion Criteria Prior treatment with natilizumab or fingolimod
Diagnosis of PPMS and or SPMS
IVIg within one year prior to study treatment
MS relapse 30 days prior to randomization

10. PASSAGE Dr. Komatineni Multiple Sclerosis
‘Long-term, prospective, multinational, parallel-cohort study monitoring safety in patients with MS newly started on Fingolimod once daily or treated with another approved disease-modifying therapy.’
Sub-Investigator, Christen Kutz
Novartis sponsored, open label 5 year safety registry
Study Drug-Fingolimod with a parallel cohort of any other DMT
Currently we have 36 patients enrolled with the maximum enrollment of 45
Inclusion Criteria
MS patients who are starting fingolimod at the time of study entry or
MS patients who have started another approved MS DMT within 6 months
Exclusion Criteria
Patients currently treated with cytoxic agents
Patients treated with any investigational drug unless this is a part of a Novartis sponsored MS study lasting less than 1 month

11. TRANSITION-PI Dr. Komatineni
Multiple Sclerosis
‘A two-year observational study to evaluate the safety profile of Fingolimod in patients with multiple sclerosis who switch from Natalizumab to Fingolimod.’
Sub-I-Christen Kutz
Currently enrolling with 7 subjects
Study Drug-Fingolimod
Inclusion Criteria
Patients starting fingolimod treatment at study entry or within the last 12 months prior to study entry
Patient must have received their last infusion of natalizumab within the last 12 months prior to the study entry
Exclusion Criteria
Patients previously treated with fingolimod at any time other than the 12 months prior to the study entry

12. Over-Active Bladder Study-PI Christen Kutz
‘Bladder Management in Patients with Multiple Sclerosis: Optimizing Practice Patterns’
Sponsor: Allergan
Currently we have 26 enrolled with the potential of enrolling up to 40 subjects
Inclusion Criteria
Patients must have overactive bladder symptoms that meet eligibility requirements gathered through a questionnaire
Exclusion Criteria
Patients have seen a urologist in the last 2 years

13. Neurosurgery Trials

14. Principal and Sub-Investigators
Dr. Hammers
Dr. Bhatti
Sara Westerhaus, PA-C

15. DuraSeal-PI Dr. Hammers
‘This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.’
Sub-Is: Dr. Bhatti, Dr. Brown, Dr. Hammers, Dr. Manon, Dr. Samuelson, Dr. Sceats
Sponsor: Integra
Study Material-DuraSeal Exact
Enrolling-waiting for product availability
Retrospective arm-enrolling

16. RAVINE-PI Dr. Bhatti
‘A Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine: K2M RAVINE® Far Lateral System Versus NuVasive XLIF®’
Sub-I: Sara Westerhaus, PA-C
Sponsor: K2M
Currently enrolling, 2 active subjects