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OpenTrials
Completed

NCT Number: NCT02588677

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

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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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Carlos III

Madrid, 28029, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Main inclusion criteria:

  • 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

Exclusion criteria

  • Patient who underwent tracheostomy and/or gastrostomy

Treatment and study plan

Masitinib (4.5)

Drug

4.5 mg/kg/day

Other names: AB1010

Riluzole

Drug

Other names: Rilutek

Placebo

Drug

Other names: Placebo Oral Tablet

Masitinib (3.0)

Drug

3 mg/kg/day

Other names: AB1010

Primary outcomes

  1. Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised

    Time frame: From baseline to week 48

    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)

Secondary outcomes

  1. Change of Forced Vital Capacity (FVC)

    Time frame: From baseline to week 48

    Forced vital capacity (FVC) measures the volume of air expelled from the lungs during a quick, forceful breath.

  2. Progression Free Survival

    Time frame: 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

    Progression Free Survival is defined as the time from the randomization date until the earliest date for a decline of more than 9-points in ALSFRS-R score

  3. Overall Survival

    Time frame: Time from the randomization date until death, asssesd over a maximum of 60 months

    Overall survival is defined as time in months from the randomization date to the date of death due to any cause.

Sponsors and collaborators

Lead sponsor

AB Science

Industry

Registry information

Official study title

Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Oct 28, 2015
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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