Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib
1 other identifier
interventional
394
1 country
1
Brief Summary
The objective is to compare the efficacy and safety of masitinib in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2013
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedSeptember 29, 2023
September 1, 2023
3.7 years
October 20, 2015
September 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised
The amyotrophic lateral sclerosis functional rating scale (ALSFRS), which is a Validated instrument that assesses the functional status and the disease progression in patients with amyotrophic lateral sclerosis (ALS)
From baseline to week 48
Secondary Outcomes (3)
Change of Forced Vital Capacity (FVC)
From baseline to week 48
Progression Free Survival
Time from the randomization date until the earliest date for a decline of more than 9-points in ALSFRS-R score, asssesd over a maximum of 60 months
Overall Survival
Time from the randomization date until death, asssesd over a maximum of 60 months
Study Arms (3)
Masitinib (3.0) & Riluzole
EXPERIMENTALmasitinib 3 mg/kg/day + riluzole
Masitinib (4.5) & Riluzole
EXPERIMENTALmasitinib 4.5 mg/kg/day (2) + riluzole
Placebo & Riluzole
PLACEBO COMPARATORMatched placebo
Interventions
Eligibility Criteria
You may qualify if:
- Familial or sporadic ALS
- Patient diagnosed with probable of definite ALS
- Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
You may not qualify if:
- \. Patient who underwent tracheostomy and/or gastrostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AB Sciencelead
Study Sites (1)
Hospital Carlos III
Madrid, 28029, Spain
Related Publications (1)
Mora JS, Bradley WG, Chaverri D, Hernandez-Barral M, Mascias J, Gamez J, Gargiulo-Monachelli GM, Moussy A, Mansfield CD, Hermine O, Ludolph AC. Long-term survival analysis of masitinib in amyotrophic lateral sclerosis. Ther Adv Neurol Disord. 2021 Jul 19;14:17562864211030365. doi: 10.1177/17562864211030365. eCollection 2021.
PMID: 34457038DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesus S Mora, MD
Unidad de ELA, Hospital San Rafael, c/ Serrano, 199, 28016 Madrid, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 28, 2015
Study Start
April 1, 2013
Primary Completion
December 5, 2016
Study Completion
March 1, 2018
Last Updated
September 29, 2023
Record last verified: 2023-09