A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Summary

This study is an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients with chronic fatigue syndrome. Subjects will be randomized to a solriamfetol group or placebo group. The investigators will utilize an intent to treat model and impute data. The overall goal of this study is to determine the efficacy and effectiveness of solriamfetol for treating chronic fatigue syndrome.

Timeline

Start

2021-04-27

Primary completion

2024-09-01

Completion

2024-12-01

Publications

• Background Hann DM, Jacobsen PB, Azzarello LM, Martin SC, Curran SL, Fields KK, Greenberg H, Lyman G. Measurement of fatigue in cancer patients: development and validation of the Fatigue Symptom Inventory. Qual Life Res. 1998 May;7(4):301-10. doi: 10.1023/a:1024929829627.
• Background Donovan KA, Jacobsen PB, Small BJ, Munster PN, Andrykowski MA. Identifying clinically meaningful fatigue with the Fatigue Symptom Inventory. J Pain Symptom Manage. 2008 Nov;36(5):480-7. doi: 10.1016/j.jpainsymman.2007.11.013. Epub 2008 May 20.
• Background Donovan KA, Jacobsen PB. The Fatigue Symptom Inventory: a systematic review of its psychometric properties. Support Care Cancer. 2010 Feb;19(2):169-85. doi: 10.1007/s00520-010-0989-4. Epub 2010 Sep 8.
• Background Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.
• Background Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.
• Background Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.
• Young JL, Powell RN, Powell A, Welling LLM, Granata L, Saal J. Solriamfetol improves daily fatigue symptoms in adults with myalgic encephalomyelitis/chronic fatigue syndrome after 8 weeks of treatment. J Psychopharmacol. 2025 Nov;39(11):1268-1276. doi: 10.1177/02698811251368371. Epub 2025 Sep 16.

Drugs

Indications