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

• Status: Completed
• Trial end date: 2019-11-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Patient-Centered Outcomes Research Institute
• Treatments: Amantadine; Armodafinil; Methylphenidate; Modafinil

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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