Trial · NCT03127267
Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
NCT03127267, Phase 3, Recruiting, AB Science
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients. Trials, record NCT03127267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03127267
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
- NCT number
- NCT03127267
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 495 participants, estimated
- Lead sponsor
- AB Science
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- Masitinib (6.0), Riluzole, Placebo, Masitinib (4.5)
- First posted
- 2017-04-25
- Last updated
- 2025-09-12
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ALSFRS-R | 48 weeks | Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised. |
| Secondary | ALSAQ-40 | 48 weeks | Change in ALS quality of life patient questionnaire (ALSAQ-40) |
| Secondary | PFS | From day of randomization to disease progression or death, assessed for a maximum of 36 months | Progression free survival (PFS) is defined as the time from randomization to progression (decline of more than 9 points in ALSFRS-R score from baseline) or death |
| Secondary | FVC | 48 weeks | Change in Forced Vital Capacity (FVC) |
| Secondary | HHD | 48 weeks | Change in evaluation of upper- and lower-limb muscle strength using hand-held dynamometry (HHD) |
| Secondary | Change in the Combined Assessment of Function and Survival (CAFS) score from baseline to week 48 | 48 weeks | CAFS ranks patients' clinical outcomes based on survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score. Each patient's outcome is compared to every other patient's outcome, assigned a score, and the summed scores are ranked. The mean rank score for each treatment group can then be calculated. A higher mean CAFS score indicates a better group outcome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36048877 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03127267
GET https://conductscience.org/api/trials/v1/NCT03127267/registered