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NCT02286557

Testing the Effects of Methylphenidate on Cognitive Fatigue in Multiple Sclerosis: a Double-blind, Placebo-controlled, Randomized Clinical Trial

Completed Phase 2 Last updated 25 August 2025
What this trial tests

Phase 2 trial testing Methelphenidate in Fatigue in Multiple Sclerosis in 36 participants. Completed in 4 March 2025.

Timeline
1 October 2014
Primary endpoint
28 February 2025
4 March 2025

Quick facts

Lead sponsorKessler Foundation
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposetreatment
Enrollment36
Start date1 October 2014
Primary completion28 February 2025
Estimated completion4 March 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Kessler Foundation

Who can join

Adults 18 to 65, any sex, with Fatigue in Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Up to 95% of individuals with Multiple Sclerosis report experiencing cognitive fatigue, characterized by a lack of energy, feelings of exhaustion, an the perception that one is unable to partake in daily activities. The goal of this project is to test whether methylphenidate (MP), a well-known psychostimulant, can effective treat fatigue experienced by individuals with MS. The current study will test the effect of MP on MS fatigue through a clinical trial. Every participant in the study will be exposed to both the drug and the placebo for a period of time. Both the investigators and participants will be unaware whether participants are receiving the drug or the placebo. Upon successful completion of the study, physicians will be able to evaluate the potential prescription of MP to treat fatigue in persons with MS based on solid research evidence. Importantly, MP is already an FDA approved widely used medication in multiple clinical populations.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Kessler Foundation trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing