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NCT07325591

Efficacy and Safety of Tazbentetol in ALS Participants

StatusNot Yet Recruiting
PhasePhase 2/3
SponsorSpinogenix
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Start date: Mar 1, 2026 to Oct 1, 2026v4
  2. Study description revisedv3
  3. Phase: Phase 2 to Phase 2/3v2 Show 6 more changesShow less
    • Primary endpoints: 2 to 3
    • Enrollment target: 336 to 430
    • Interventions: Tazbentetol 300 mg once daily (Drug), Tazbentetol 300 mg twice daily (Drug), placebo (Drug) to Tazbentetol (Drug), placebo (Drug)
    • Secondary endpoints: 14 to 21
    • Study description expanded, about 18 words
    • Study arms: 3 to 2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase 2: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score
Timeframe: 36 weeks
Phase 3: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score
Timeframe: 36 weeks
OLE: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score
Timeframe: 36 weeks

Secondary (21)

Phase 2: Combined Assessment of Function and Survival (CAFS) scores
Phase 2: Change from baseline in Clinician Global Impression-Inhibitory (CGI-I)
Phase 2: Change from baseline in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
Phase 2: Change from baseline in ALS Assessment Questionnaire 40 items (ALSAQ-40)
Phase 2: Change from baseline in Patient Global Impression (PGI) of Improvement
Show 16 moreShow less
Phase 2: Change from baseline in Rasch Overall ALS Disability (ROADS).
Phase 2: Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Phase 3: Combined Assessment of Function and Survival (CAFS) scores
Phase 3: Change from baseline in Clinician Global Impression-Inhibitory (CGI-I)
Phase 3: Change from baseline in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
Phase 3: Change from baseline in ALS Assessment Questionnaire 40 items (ALSAQ-40)
Phase 3: Change from baseline in Patient Global Impression (PGI) of Improvement
Phase 3: Change from baseline in Rasch Overall ALS Disability (ROADS).
Phase 3: Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
OLE: Combined Assessment of Function and Survival (CAFS) scores
OLE: Change from baseline in Clinician Global Impression-Inhibitory (CGI-I)
OLE: Change from baseline in ALS Assessment Questionnaire 40 items (ALSAQ-40)
OLE: Change from baseline in Edinburgh Cognitive and Behavioural ALS Screen (ECAS)
OLE: Change from baseline in Patient Global Impression (PGI) of Improvement
OLE: Change from baseline in Rasch Overall ALS Disability (ROADS).
OLE: Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Arms and interventions

tazbentetolExperimental

synthetic small molecule

PlaceboPlacebo comparator

placebo

Drugs: Tazbentetol, placebo