CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 141 enrolled
Drug / intervention
Amantadine +3 moredrug
Likely dose
Amantadine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03185065
NCT03185065Phase 3Completed
CompareCT.gov

Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis

Johns Hopkins University·interventional·Posted Jun 14, 2017·Updated Oct 20, 2020

In Brief

A Phase 3 clinical trial evaluating Amantadine, Modafinil, and 2 other interventions for Fatigue in Multiple Sclerosis. Completed, enrolled 141 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue in Multiple Sclerosis
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartOct 4, 2017
Primary CompletionNov 21, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.0 years ago

Interventions

Amantadinedrug

100 mg of amantadine increased to 200 mg of amantadine, if tolerated

Modafinildrug

100 mg of modafinil increased to 200 mg of modafinil, if tolerated

Methylphenidatedrug

5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated

Placebosdrug

1 placebo capsule increased to max of 2 capsules twice daily