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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588677
• Other study ID #: AB10015
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2013
• Est. completion date: March 2018

Study information

• Verified date: September 2023
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: March 2018
• Est. primary completion date: December 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Masitinib (4.5)
4.5 mg/kg/day
• Riluzole

• Placebo

• Masitinib (3.0)
3 mg/kg/day

Locations

Country	Name	City	State
Spain	Hospital Carlos III	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Forced Vital Capacity (FVC)	Forced vital capacity (FVC) measures the volume of air expelled from the lungs during a quick, forceful breath.	From baseline to week 48
Secondary	Progression Free Survival	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
Secondary	Overall Survival	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