Testing the Effects of Methylphenidate on Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02286557
• Date of registration: 16/10/2014
• Prospective Registration: No
• Primary sponsor: Kessler Foundation
• Public title: Testing the Effects of Methylphenidate on Multiple Sclerosis
• Scientific title: Testing the Effects of Methylphenidate on Cognitive Fatigue in Multiple Sclerosis: a Double-blind, Placebo-controlled, Randomized Clinical Trial
• Date of first enrolment: October 2014
• Target sample size: 36
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT02286557
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fatigue in Multiple Sclerosis

Intervention(s)

Drug: Methelphenidate

Drug: Placebo

Primary Outcome(s)

Fatigue - Modified Fatigue Impact Scale [Time Frame: baseline, day 30 and day 68]

Secondary Outcome(s)

Processing Speed - Symbol Digit Modalities Test [Time Frame: baseline, day 30 and day 68]

Secondary ID(s)

PP2280

Source(s) of Monetary Support

Please refer to primary and secondary sponsors