NCT07325591Not yet recruitingPhase 2/3
Efficacy and Safety of Tazbentetol in ALS Participants
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)
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 430 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Spinogenix
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07325591
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 430
- From 1 Oct 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Vaccines within 14 days
- Other investigational products within 30 days
Other illness
- 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
- Neurodegenerative disease
- HIV, hepatitis B and hepatitis C positive
Other
- Active cigarette smokers and users of nicotine-containing products
- External respiratory support or supplemental oxygen requirement
- Blood donation within 30 days
- Plasma donation within 7 days
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.