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

September 27, 2023 updated by: AB Science

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28029
        • Hospital Carlos III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Masitinib (3.0) & Riluzole
masitinib 3 mg/kg/day + riluzole
Drug: Riluzole
Other Names:
  • Rilutek
Drug: Masitinib (3.0)
3 mg/kg/day
Other Names:
  • AB1010
Experimental: Masitinib (4.5) & Riluzole
masitinib 4.5 mg/kg/day (2) + riluzole
Drug: Riluzole
Other Names:
  • Rilutek
Drug: Masitinib (4.5)
4.5 mg/kg/day
Other Names:
  • AB1010
Placebo Comparator: Placebo & Riluzole
Matched placebo
Drug: Placebo
Other Names:
  • Placebo Oral Tablet
Drug: Riluzole
Other Names:
  • Rilutek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline to week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to week 48
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
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 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.
Time from the randomization date until death, asssesd over a maximum of 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AB Science

Investigators

  • Principal Investigator: Jesus S Mora, MD, Unidad de ELA, Hospital San Rafael, c/ Serrano, 199, 28016 Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 5, 2016

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimated)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB10015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis (ALS)

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe