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Efficacy and Safety of Tazbentetol in ALS Participants
Sponsor: Spinogenix
Summary
The objectives of this study are to examine the effects of tazbentetol on clinical measures of ALS, patient reported outcomes (PROs), long-term safety and tolerability.
Official title: A Phase 2B/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tazbentetol in Participants With Amyotrophic Lateral Sclerosis (ALS)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2026-03-01
Completion Date
2028-03-01
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Tazbentetol
Participants in both Phase 2B and Phase 3 will be randomized to received study drug tazbentetol or placebo tablets. Participants in the open-label extension phase will receive the dose determined from Phase 2.
placebo
participants in double blind placebo controlled phase will be randomized to received placebo tablets