Study Purpose:
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).Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Masitinib (4.5), Riluzole, Placebo, Masitinib (3.0)
Placebo:
Phase:
Phase 2/Phase 3
Study Chair(s)/Principal Investigator(s):
Jesus S Mora, MD, Unidad de ELA, Hospital San Rafael, c/ Serrano, 199, 28016 Madrid, Spain
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Madrid, United States
Full Study Summary:
Masitinib is novel tyrosine kinase inhibitor that targets microglia and mast cells through inhibiting a limited number of kinases. Masitinib blocks microglia proliferation and activation, and mast cell-mediated degranulation, the release of cytotoxic substances that might further damage the motor nerves.
There are two distinct populations of ALS patients: population of "Normal progressors" and population of "Faster progressors". Targeted population for primary analysis is population of "Normal progressors".
"Normal progressors" are ALS patients whose progression of ALSFRS-R score before randomization is less than 1.1 point per month.
There are two distinct populations of ALS patients: population of "Normal progressors" and population of "Faster progressors". Targeted population for primary analysis is population of "Normal progressors".
"Normal progressors" are ALS patients whose progression of ALSFRS-R score before randomization is less than 1.1 point per month.
Study Sponsor:
AB Science
Participant Duration:
up to 48 weeks
Estimated Enrollment:
394
Estimated Study Start Date:
03 / 31 / 2014
Estimated Study Completion Date:
03 / 01 / 2018
Posting Last Modified Date:
12 / 17 / 2018
Date Study Added to neals.org:
10 / 28 / 2015
This trial is currently not recruiting in the United States.
https://clinicalt...CT02588677&rank=1
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:Main inclusion criteria:
1. Familial or sporadic ALS
2. Patient diagnosed with probable of definite ALS
3. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
Exclusion Criteria:
1. Patient who underwent tracheostomy and/or gastrostomy
Hospital Carlos III
Madrid 28029
Spain