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

NCT02588677 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2023-09-29

No results posted yet for this study

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).

Conditions

  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

Masitinib (4.5)

4.5 mg/kg/day

DRUG

Riluzole

DRUG

Placebo

DRUG

Masitinib (3.0)

3 mg/kg/day

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-12-05
Completion
2018-03-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02588677 on ClinicalTrials.gov