Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis (ALS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Masitinib (3.0) & Riluzole

masitinib 3 mg/kg/day + riluzole

Group Type EXPERIMENTAL

Riluzole

Intervention Type DRUG

Masitinib (3.0)

Intervention Type DRUG

3 mg/kg/day

Masitinib (4.5) & Riluzole

masitinib 4.5 mg/kg/day (2) + riluzole

Group Type EXPERIMENTAL

Masitinib (4.5)

Intervention Type DRUG

4.5 mg/kg/day

Riluzole

Intervention Type DRUG

Placebo & Riluzole

Matched placebo

Group Type PLACEBO_COMPARATOR

Riluzole

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Masitinib (4.5)

4.5 mg/kg/day

Intervention Type DRUG

Riluzole

Intervention Type DRUG

Placebo

Intervention Type DRUG

Masitinib (3.0)

3 mg/kg/day

Intervention Type DRUG

Other Intervention Names

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AB1010 Rilutek Placebo Oral Tablet AB1010

Eligibility Criteria

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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