Overview

Testing the Effects of Methylphenidate on Multiple Sclerosis

Status:
Unknown status
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kessler Foundation
Treatments:
Methylphenidate
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.