NCT06843382Not yet recruiting
Real-world Experience of Oral Agents On Fatigability in Multiple Sclerosis
Real-World Comparative Effects of Teriflunomide and Dimethyl Fumarate on Physical and Cognitive Fatigability in Multiple Sclerosis: The ROOF-MS Multicenter Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
This multicenter, prospective, real-world study evaluates how two commonly used oral disease-modifying therapies-teriflunomide and dimethyl fumarate-affect physical and cognitive fatigability in adults with multiple sclerosis (MS). Fatigability refers to an objective decline in physical or cognitive performance during sustained activity and represents a major barrier to daily functioning for many individuals with MS. Participants starting either teriflunomide or dimethyl fumarate as part of routine clinical care will be followed for 12 months at regular visits (baseline, 3, 6, 9, and 12 months). At each visit, standardized assessments will measure walking endurance, gait performance, hand function, and information-processing speed. Patient-reported outcomes about fatigue, mood, quality of life, and daily functioning will also be collected. Brain MRI scans performed as part of usual care will be reviewed to document disease activity. The goal of the ROOF-MS study is to understand whether these two therapies differ in their impact on physical and cognitive fatigability, functional outcomes, symptom burden, and real-world treatment adherence. Because this is an observational study, no experimental treatments are given, and all clinical decisions remain the responsibility of the treating physicians. By examining fatigability in everyday clinical settings, this study aims to generate evidence that can help patients, families, and health care providers make more informed treatment decisions.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- 20 Nov 2025
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- TC Erciyes University
- Diseases
- Multiple sclerosis
- NCT number
- NCT06843382
What you commit to
- Study type: Observational
- Planned participants: 100
- From 20 Nov 2025 to the primary completion date, 15 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe comorbidities affecting mobility or cognitive function (e.g., advanced cardiovascular, pulmonary, or neuromuscular disease).
- Neurological or psychiatric conditions that prevent cognitive testing (e.g., advanced cognitive impairment, untreated severe depression).
Other
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS).
- Severe upper extremity motor dysfunction, limiting 9-Hole Peg Test (9-HPT) or Symbol Digit Modalities Test (SDMT) completion.
- Pregnancy or breastfeeding at the time of enrollment.
- Inability to comply with study visits at baseline, 3 months, 6 months, and 12 months.
Who the study is looking for
- Relapsing Multiple Sclerosis (RRMS or active SPMS) diagnosis, confirmed according to the 2017 revised McDonald criteria.
- 18 years or older at the time of enrollment.
- Newly initiated teriflunomide treatment as part of routine clinical care.
- Ambulatory status (EDSS ≤ 7.0), capable of completing study assessments.
- Ability and willingness to provide informed consent and comply with study procedures.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erciyes University Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.