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

Completed · Phase 3 · Has a placebo group

Conditions studied: Fatigue in Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03185065

Run by

Johns Hopkins University

People needed

141

Starts

2017-10-04

Expected to finish

2019-11-21

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years and older.
• Females of childbearing age must have a negative urine pregnancy test at baseline and use an effective method of contraception during the study.
• Diagnosis of MS (according to the 2010 McDonald criteria).
• Expanded Disability Status Scale (EDSS) score at the time of screening 0.0-7.0.
• Fatigue reportedly present and screening Modified Fatigue Impact Scale (MFIS) score more than 33.
• At least a two-week washout for any fatigue-related drug, including study medications.

You may not qualify if…

• Neurodegenerative disorders other than relapsing or progressive MS.
• Breastfeeding or pregnant.
• History of coronary artery disease or congestive heart failure.
• Uncontrolled hypertension at screening (history of high blood pressure and screening systolic blood pressure >160 or diastolic blood pressure>100).
• Glomerular Filtration Rate (GFR) (glomerular filtration rate) < 50.
• Abnormal liver function at screening (AST or Alanine Aminotransferase (ALT) more than twice the upper limit of normal).
• Terminal medical conditions.
• Currently treated for active malignancy.
• Planned surgery or move within 8 months of screening.
• Alcohol or substance abuse in the past year (except marijuana or other cannabinoids).
• A history of intolerance or allergic or anaphylactic reaction to amantadine, modafinil, methylphenidate or any component of the preparation.
• Clinically unstable medical or psychiatric disorders that require acute treatment as determined by the PI.
• Concurrent use of monoamine oxidase inhibitors-B.
• Hypersensitivity/idiosyncrasy to sympathomimetic amines
• Inability to communicate or answer the questionnaires in English or Spanish.
• Severe untreated anemia (blood hemoglobin <9gr/dl)
• History of untreated hypothyroidism
• History of untreated sleep apnea
• History of long QT syndrome, atrial fibrillation or tachyarrhythmias (other than sinus tachycardia)
• History of ischemic or hemorrhagic stroke
• History of glaucoma
• History of Tourette syndrome

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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