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Efficacy and Safety of Tazbentetol in ALS Participants

NCT07325591 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

DRUG

placebo

participants in double blind placebo controlled phase will be randomized to received placebo tablets

Sponsors & Collaborators

  • Spinogenix

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-12-31
Completion
2028-03-01
FDA Drug
Yes

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325591 on ClinicalTrials.gov