RECRUITING

Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients

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Conditions

Amyotrophic Lateral SclerosisALSTyrosine kinase inhibitorLou Gehrig's diseaseCharcot's diseaseMotor Neuron diseaseMND

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective is to compare the efficacy and safety of masitinib in combination with riluzole versus matched placebo in combination with riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Official Title

Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

Quick Facts

Study Start:2021-02-02
Study Completion:2023-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03127267

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.

Ages Eligible for Study:18 Years to 81 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Study Coordinator
CONTACT
+33(0)147200014
clinical@ab-science.com

Principal Investigator

Albert Ludolph, MD, PhD
PRINCIPAL_INVESTIGATOR
Department of Neurology, University of Ulm, Germany

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of Southern California
Los Angeles, California, 90007
United States
University of Kentucky
Lexington, Kentucky, 40506
United States
Johns Hopkins Medicine Brain Science Institute
Baltimore, Maryland, 21205
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
United States
University of Virginia Health System
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: AB Science

  • Albert Ludolph, MD, PhD, PRINCIPAL_INVESTIGATOR, Department of Neurology, University of Ulm, Germany

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 Registration Dates

Study Start Date2021-02-02
Study Completion Date2023-12

Study Record Updates

Study Start Date2021-02-02
Study Completion Date2023-12

Terms related to this study

Keywords Provided by Researchers

  • Amyotrophic Lateral Sclerosis
  • ALS
  • Tyrosine kinase inhibitor
  • Lou Gehrig's disease
  • Charcot's disease
  • Motor Neuron disease
  • MND

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis