Testing the Effects of Methylphenidate on Multiple Sclerosis

NCT02286557 | Completed Phase 2 DMC

• 1 other identifier: PP2280
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fatigue in Multiple Sclerosis

Keywords

Methylphenidate; Multiple Sclerosis; Cognitive Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue - Modified Fatigue Impact Scale

  Changes on fatigue levels from baseline, will be assess after 4 weeks, and after 10 weeks of the duration of the study.

  baseline, day 30 and day 68

Secondary Outcomes (1)

• Processing Speed - Symbol Digit Modalities Test

  baseline, day 30 and day 68

Study Arms (2)

Arm I

EXPERIMENTAL

Arm 1 will undergo four weeks of treatment with MP extended-release (20 mg/day in the morning). Following the four weeks of treatment, all assessments performed at baseline will be repeated. To minimize practice effects, alternate versions of the neuropsychological tests will be used wherever available. A 7-day washout period will follow in which no medication will be administered. Following the washout period, Arm 1 will undergo four weeks of placebo. This will be followed by a final assessment consisting of measures of fatigue, cognitive functioning, and physical disability.

Drug: Methelphenidate; Drug: Placebo

Arm II

EXPERIMENTAL

Arm 2 will undergo four weeks of placebo (in the morning). Following the four weeks of placebo, all assessments performed at baseline will be repeated. To minimize practice effects, alternate versions of the neuropsychological tests will be used wherever available. A 7-day washout period will follow in which no medication will be administered. Following the washout period, Arm 2 will undergo four weeks of treatment with MP extended-release (20mg/day). This will be followed by a final assessment consisting of measures of fatigue, sleep quality, cognitive functioning, and physical disability.

Drug: Methelphenidate; Drug: Placebo

Interventions

Methelphenidate DRUG

All participants will undergo 4 weeks of treatment with Methelphenidate and 4 weeks of placebo

Arm I; Arm II

Placebo DRUG

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Multiple Sclerosis
• Age: 18-65 years old

You may not qualify if:

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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: November 10, 2014
• Study Start: October 1, 2014
• Primary Completion: February 28, 2025
• Study Completion: March 4, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)