drugset / Trial / NCT03185065
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis
Phase 3
Completed
141 enrolled
Johns Hopkins University
Patient-Centered Outcomes Research Institute · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
Randomized, placebo-controlled, crossover, 4-sequence, 4-period, double-blind (participants and investigators), multicenter trial of 3 commonly used medications for treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS defined by McDonald Criteria.
Timeline
- Start
- 2017-10-04
- Primary completion
- 2019-11-21
- Completion
- 2019-11-21
Outcome
Missed primary endpoint
paper p=0·20 for the overall medication effect in the linear mixed-effect regression model). PMID 33242419 ↗
paper Amantadine, modafinil, and methylphenidate were not superior to placebo in improving multiple sclerosis fatigue PMID 33242419 ↗
Publications
- Nourbakhsh B, Revirajan N, Morris B, Cordano C, Creasman J, Manguinao M, Krysko K, Rutatangwa A, Auvray C, Aljarallah S, Jin C, Mowry E, McCulloch C, Waubant E. Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. Lancet Neurol. 2021 Jan;20(1):38-48. doi: 10.1016/S1474-4422(20)30354-9. Epub 2020 Nov 23.
- Nourbakhsh B, Revirajan N, Waubant E. Treatment of fatigue with methylphenidate, modafinil and amantadine in multiple sclerosis (TRIUMPHANT-MS): Study design for a pragmatic, randomized, double-blind, crossover clinical trial. Contemp Clin Trials. 2018 Jan;64:67-76. doi: 10.1016/j.cct.2017.11.005. Epub 2017 Nov 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amantadine | Unknown | 200 mg | Oral |
| Subject | Methylphenidate | Small molecule | 20 mg | Oral |
| Subject | Modafinil | Small molecule | 200 mg | Oral |