Last reviewed · How we verify
NCT02286557
Testing the Effects of Methylphenidate on Cognitive Fatigue in Multiple Sclerosis: a Double-blind, Placebo-controlled, Randomized Clinical Trial
Phase 2 trial testing Methelphenidate in Fatigue in Multiple Sclerosis in 36 participants. Completed in 4 March 2025.
28 February 2025
Quick facts
| Lead sponsor | Kessler Foundation |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 October 2014 |
| Primary completion | 28 February 2025 |
| Estimated completion | 4 March 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Methelphenidate — full drug profile →
- Placebo
Conditions studied
- Fatigue in Multiple Sclerosis — all drugs for Fatigue in Multiple Sclerosis →
Sponsor
Kessler Foundation
Who can join
Adults 18 to 65, any sex, with Fatigue in Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Fatigue - Modified Fatigue Impact Scale
Time frame: baseline, day 30 and day 68
Changes on fatigue levels from baseline, will be assess after 4 weeks, and after 10 weeks of the duration of the study.
Sponsor's own description
Up to 95% of individuals with Multiple Sclerosis report experiencing cognitive fatigue, characterized by a lack of energy, feelings of exhaustion, an the perception that one is unable to partake in daily activities. The goal of this project is to test whether methylphenidate (MP), a well-known psychostimulant, can effective treat fatigue experienced by individuals with MS. The current study will test the effect of MP on MS fatigue through a clinical trial. Every participant in the study will be exposed to both the drug and the placebo for a period of time. Both the investigators and participants will be unaware whether participants are receiving the drug or the placebo. Upon successful completion of the study, physicians will be able to evaluate the potential prescription of MP to treat fatigue in persons with MS based on solid research evidence. Importantly, MP is already an FDA approved widely used medication in multiple clinical populations.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02286557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Kessler Foundation trials
Trials by the same sponsor.
- NCT07168941 — Evaluation and Refinement of KF-STRIDE Into the Interview! · NA · not yet recruiting
- NCT07159100 — tDCS for Cancer-Related Fatigue and Weakness · EARLY_PHASE1 · not yet recruiting
- NCT06886152 — Spinal Stimulation and Gait Training to Improve Mobility in TBI · NA · not yet recruiting
- NCT07073313 — Using Muscle Functional MRI to Study Spatial Muscle Activation Patterns in People With SCI · not yet recruiting
- NCT06923293 — Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02286557 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kessler Foundation
- Last refreshed: 25 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02286557.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing