Efficacy and Safety of Tazbentetol in ALS Participants

Sponsor
Spinogenix
Study ID
NCT07325591
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tazbentetol — DRUG
    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 — DRUG
    participants in double blind placebo controlled phase will be randomized to received placebo tablets

Study Details

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.

Key Dates

First listed
Jan 8, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
430 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tazbentetol
    synthetic small molecule
  • Placebo Comparator: Placebo
    placebo

Primary Outcome Measure

Phase 2: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score [ Time Frame: 36 weeks ]

Central Contacts

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