NCT03127267 Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
| NCT ID | NCT03127267 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AB Science |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 495 participants |
| Start Date | 2021-02-02 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 495 participants in total. It began in 2021-02-02 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).
Eligibility Criteria
Main inclusion criteria include: * Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria * Patient with a familial or sporadic ALS * ALS disease duration from diagnosis no longer than 24 months at the screening visit * Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit * Patient with an ALSFRS-R score progression between onset of the disease and screening of \> 0.3 per month, confirmed with an ALSFRS-R score progression of ≥ 1 point during a 12-week run-in period between screening and randomization. * Patient with a score, at screening, of at least 26 overall, including a score of at least 3 on item #3 and at least 2 on each of the 12 ALSFRS-R individual component items and with a score, at randomization, of at least 2 on each of the 12 ALSFRS-R individual component items Main exclusion criteria include: * Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results * Patient with a FVC \< 60% predicted normal value for gender, height, and age at screening and baseline * Pregnant, or nursing female patient
Contact & Investigator
Albert Ludolph, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Neurology, University of Ulm, Germany
Frequently Asked Questions
Who can join the NCT03127267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 81 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03127267 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 495 participants.
Is NCT03127267 currently recruiting?
Yes, NCT03127267 is actively recruiting participants. Contact the research team at clinical@ab-science.com for enrollment information.
Where is the NCT03127267 trial being conducted?
This trial is being conducted at Birmingham, United States, Los Angeles, United States, Lexington, United States, Baltimore, United States and 11 additional locations.
Who is sponsoring the NCT03127267 clinical trial?
NCT03127267 is sponsored by AB Science. The principal investigator is Albert Ludolph, MD, PhD at Department of Neurology, University of Ulm, Germany. The trial plans to enroll 495 participants.
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