Menu
Not yet recruiting NCT07325591

Efficacy and Safety of Tazbentetol in ALS Participants

Phase II / Phase III Interventional Amyotrophic Lateral Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tazbentetol, placebo.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Detailed description

This is a Phase 2B/3 adaptive design randomized, double-blind, placebo-controlled (DBPC) study to evaluate the efficacy, safety and tolerability of tazbentetol administered orally in participants with ALS.

The study consists of 2 parts, as follows

Phase 2 double-blind, placebo controlled (DBPC): Randomized, double-blind, placebo-controlled study. Participants will be randomized to receive tazbentetol or placebo for 36 weeks.

Phase 3 double blind, placebo controlled (DBPC): Randomized, double-blind, placebo-controlled study. Participants will be randomized to receive the dose determined from Phase 2 or placebo for 36 weeks.

Open-label extension: Eligible participants who complete 36 weeks in the DBPC of either Phase 2 or Phase 3 will be offered to enroll into the OLE, starting at the corresponding DBPC Week 36 visit, and receive tazbentetol for 36 weeks. The dose for this extension will be based on data from DBPC phases.

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

Primary outcome measures

  • Phase 2: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score [Time frame: 36 weeks]
  • Phase 3: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score [Time frame: 36 weeks]
  • OLE: Absolute change from baseline in Amyotrophic Lateral Sclerosis Functional Rating Scale-revised (ALSFRS-R) total score [Time frame: 36 weeks]
Secondary outcome measures (12)
  • Phase 2: Combined Assessment of Function and Survival (CAFS) scores [Time frame: 36 weeks]
  • Phase 2: Change from baseline in Clinician Global Impression-Inhibitory (CGI-I) [Time frame: 36 weeks]
  • Phase 2: Change from baseline in Edinburgh Cognitive and Behavioural ALS Screen (ECAS) [Time frame: 36 weeks]
  • Phase 2: Change from baseline in ALS Assessment Questionnaire 40 items (ALSAQ-40) [Time frame: 36 weeks]
  • Phase 2: Change from baseline in Patient Global Impression (PGI) of Improvement [Time frame: 36 weeks]
  • Phase 2: Change from baseline in Rasch Overall ALS Disability (ROADS). [Time frame: 36 weeks]
  • Phase 2: Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) [Time frame: 36 weeks]
  • Phase 3: Combined Assessment of Function and Survival (CAFS) scores [Time frame: 36 weeks]
  • Phase 3: Change from baseline in Clinician Global Impression-Inhibitory (CGI-I) [Time frame: 36 weeks]
  • Phase 3: Change from baseline in Edinburgh Cognitive and Behavioural ALS Screen (ECAS) [Time frame: 36 weeks]
  • Phase 3: Change from baseline in ALS Assessment Questionnaire 40 items (ALSAQ-40) [Time frame: 36 weeks]
  • Phase 3: Change from baseline in Patient Global Impression (PGI) of Improvement [Time frame: 36 weeks]

Eligibility criteria

Inclusion criteria

  • Age 18-80
  • ALS TRICALS risk score
  • Stable dose of standard of care treatment
  • Contraception use by men or women consistent with local regulations
  • Able and willing to provide written informed consent

Exclusion criteria

  • Underlying physical or psychological condition prohibiting study completion
  • Clinically significant cardiac disease
  • Active or history of malignancy in the past 5 years
  • Serious infection within 1 month of screening
  • Acute illness within 30 days of Day 1
  • History of suicidal behavior or suicidal ideation
  • Active cigarette smokers and users of nicotine-containing products
  • Neurodegenerative disease
  • External respiratory support or supplemental oxygen requirement
  • HIV, hepatitis B and hepatitis C positive
  • Vaccines within 14 days
  • Other investigational products within 30 days
  • Blood donation within 30 days
  • Plasma donation within 7 days
  • Pregnant or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07325591 · SPG302-ALS-003 (SPARK)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗