3 completed, 1 terminated, 1 withdrawn. 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice Monomethyl Fumarate - Relapsing Remitting Multiple Sclerosis | Terminated | Banner Life Sciences LLC | 25 | 2023-08-17 | 2025-03-06 | |
| Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate monomethyl fumarate - Relapsing Remitting Multiple Sclerosis | Withdrawn | Banner Life Sciences LLC | 2021-06-30 | 2021-11-18 | ||
| Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects Monomethyl Fumarate 190 Mg, Diroximel Fumarate 462 mg - Relapsing Remitting Multiple Sclerosis | Phase 1 | Completed | Banner Life Sciences LLC | 46 | 2021-05-14 | 2022-01-06 |
| Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers Bafiertam, Tecfidera - Multiple Sclerosis | Phase 1 | Completed | Banner Life Sciences LLC | 210 | 2019-07-07 | 2020-01-18 |
| Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects monomethyl fumarate 190 mg, dimethyl fumarate 240 mg - Relapsing Remitting Multiple Sclerosis | Phase 1 | Completed | Banner Life Sciences LLC | 50 | 2017-01-06 | 2022-12-30 |
Multiple Sclerosis, Relapsing-Remitting (4) · Multiple Sclerosis (1)
monomethyl fumarate (5) · Dimethyl Fumarate (2) · diroximel fumarate (1)
United States (3) · Puerto Rico (1)
Franck Rousseau, MD (2) · Kathleen Doisy, MD (1) · Thomas Lategan, PhD (1) · Thomas W Lategan, D.Phil. (1)