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Placebo matching DMF
This is a placebo formulation designed to match the appearance and administration characteristics of dimethyl fumarate (DMF) for blinded clinical trial purposes.
This is a placebo formulation designed to match the appearance and administration characteristics of dimethyl fumarate (DMF) for blinded clinical trial purposes. Used for Relapsing-remitting multiple sclerosis (as control in Phase 3 trials).
At a glance
| Generic name | Placebo matching DMF |
|---|---|
| Sponsor | Biogen |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Placebo matching DMF serves as an inert control in Phase 3 trials to maintain blinding while mimicking the physical and sensory properties of the active DMF drug. DMF itself is an immunomodulator that activates the Nrf2 pathway and reduces pro-inflammatory cytokines; the placebo allows researchers to isolate the true therapeutic effect of DMF from placebo response in multiple sclerosis studies.
Approved indications
- Relapsing-remitting multiple sclerosis (as control in Phase 3 trials)
Common side effects
Key clinical trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
- Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus (PHASE3)
- A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis (PHASE2)
- Alternate Dosing Regimens of BG00012 in Healthy Volunteers (PHASE1)
- Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®) (PHASE3)
- Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera (PHASE4)
- An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) (PHASE3)
- BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |