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Compares treatment options for Amyotrophic Lateral Sclerosis
Official title Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
ClinicalTrials.gov ID: NCT03127267
What this study is testing
What is Masitinib (6.0)?
Masitinib (6.0) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for amyotrophic lateral sclerosis.
Also referred to as AB1010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 81
You may be able to join if
- Main include:
- Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El...
- 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
You likely can't join if
- include:
- Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of...
- Patient with a FVC \< 60% predicted normal value for gender, height, and age at screening and baseline
- Pregnant, or nursing female patient
See the full eligibility criteria
- Main 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Burlington, Massachusetts, United States
- Charlottesville, Virginia, United States
- Leuven, Belgium
- Copenhagen, Denmark
- Angers, France
- Bordeaux, France
- Bron, France
- Clermont-Ferrand, France
- Lille, France
- Limoges, France
- Marseille, France
- Montpellier, France
- Nancy, France
- Nice, France
- Tours, France
- Ulm, Germany
+ 31 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 81 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Lexington, Kentucky, United States; Baltimore, Maryland, United States; Burlington, Massachusetts, United States; Charlottesville, Virginia, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.