Phase 3
N=141
Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis
Fatigue in Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03185065 ↗Enrolled (actual)
141
Serious AEs
0.6%
Results posted
Oct 2020
Primary outcome: Primary: Modified Fatigue Impact Scale (MFIS) Score — 40.6; 41.3; 39.0; 38.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amantadine (Drug); Modafinil (Drug); Methylphenidate (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Fatigue Impact Scale (MFIS) Score |
40.6; 41.3; 39.0; 38.6 | — |
| SECONDARY Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score |
53.1; 53.0; 52.5; 52.0 | — |
| SECONDARY Epworth Sleepiness Scale (ESS) Score |
9.4; 9.3; 8.3; 8.8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03185065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.