Armodafinil for Sarcoidosis-Associated Fatigue: A Double-Blind, Placebo-Controlled, Crossover Trial Elyse E. Lower, MD, Atul Malhotra, MD, Victoria Surdulescu, MD, Robert P. Baughman, MD Journal of Pain and Symptom Management Volume 45, Issue 2, Pages 159-169 (February 2013) DOI: 10.1016/j.jpainsymman.2012.02.016 Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 1 Flow diagram summarizing the double-blind, placebo-controlled, crossover design of the study. Overnight sleep studies followed by multiple sleep latency tests (MSLT) were performed prior to randomization and at the end of each eight-week treatment period. Journal of Pain and Symptom Management 2013 45, 159-169DOI: (10.1016/j.jpainsymman.2012.02.016) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 2 CONSORT diagram22 detailing the outcome of studied patients. Ten patients were unable or unwilling to undergo an initial sleep study. After the initial sleep study, five patients were excluded from further study because of inadequately controlled sleep apnea or restless leg syndrome. Fourteen patients completed all 19 weeks of the study as detailed in Fig. 1. Journal of Pain and Symptom Management 2013 45, 159-169DOI: (10.1016/j.jpainsymman.2012.02.016) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 3 The change of the Fatigue Assessment Scale (FAS) score after four or eight week of therapy compared with the baseline value (Week 1 or 11). There was a significant difference between armodafinil and placebo after eight weeks of therapy (P=0.0295). Journal of Pain and Symptom Management 2013 45, 159-169DOI: (10.1016/j.jpainsymman.2012.02.016) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions
Fig. 4 The change of the Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-F) score after four or eight week of therapy compared with the baseline value (Week 1 or 11). There was a significant difference between armodafinil and placebo after four and eight weeks of therapy (P=0.0149 and P=0.0040, respectively). Journal of Pain and Symptom Management 2013 45, 159-169DOI: (10.1016/j.jpainsymman.2012.02.016) Copyright © 2013 U.S. Cancer Pain Relief Committee Terms and Conditions