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

CompletedPhase 2MS (type not specified)NCT02286557

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 20 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Methelphenidate

Placebo

  • Placebo

What it measured

Main measures

  • Fatigue - Modified Fatigue Impact Scale

    baseline, day 30 and day 68

    Fatigue

Other measures (1)

  • Processing Speed - Symbol Digit Modalities Test

    baseline, day 30 and day 68

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

1. Diagnosis of Multiple Sclerosis 2. Age: 18-65 years old

Exclusion criteria

1. Participants must be free of: corticosteroids, cannot be currently taking modafinil, amantadine or other psychostimulants. 2. Participants must be MS relapse free at least during the previous 4 weeks. 3. Participants cannot consume more than ≧300mg of caffeine per day. 4. Thyroid disease 5. Anemia 6. Decreased vitamin D.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Oct 2014

    2. Main results due

      Feb 2025

    3. Finished

      Mar 2025

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