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Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis

NCT03185065 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2020-10-20

Study results available
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Summary

Randomized, placebo-controlled, crossover, 4-sequence, 4-period, double-blind (participants and investigators), multicenter trial of 3 commonly used medications for treatment of MS-related fatigue (amantadine, modafinil, methylphenidate) versus placebo in fatigued subjects with MS defined by McDonald Criteria.

Conditions

  • Fatigue in Multiple Sclerosis

Interventions

DRUG

Amantadine

100 mg of amantadine increased to 200 mg of amantadine, if tolerated

DRUG

Modafinil

100 mg of modafinil increased to 200 mg of modafinil, if tolerated

DRUG

Methylphenidate

5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated

DRUG

Placebos

1 placebo capsule increased to max of 2 capsules twice daily

Sponsors & Collaborators

Principal Investigators

  • Bardia Nourbakhsh, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-04
Primary Completion
2019-11-21
Completion
2019-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185065 on ClinicalTrials.gov