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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03185065
• Date of registration: 09/06/2017
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis TRIUMPHANT-MS
• Scientific title: Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis
• Date of first enrolment: October 4, 2017
• Target sample size: 141
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03185065
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Bardia Nourbakhsh, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fatigue in Multiple Sclerosis

Intervention(s)

Drug: Methylphenidate

Drug: Amantadine

Drug: Placebos

Drug: Modafinil

Primary Outcome(s)

Modified Fatigue Impact Scale (MFIS) Score [Time Frame: Week 5 of each treatment period]

Secondary Outcome(s)

Quality of Life in Neurological Disorders (Neuro-QoL) Item Bank - Fatigue Score [Time Frame: Week 5 of each treatment period]

Epworth Sleepiness Scale (ESS) Score [Time Frame: Week 5 of each treatment period]

Secondary ID(s)

IRB00119702

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Patient-Centered Outcomes Research Institute

Results

• Results available: Yes
• Date Posted: 19/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03185065