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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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ClinicalTrials.gov Identifier: NCT02588677
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
AB Science

Brief 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).

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: Masitinib (AB1010) Drug: Riluzole Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib
Study Start Date : April 2013
Actual Primary Completion Date : December 5, 2016
Actual Study Completion Date : March 2017


Arm Intervention/treatment
Experimental: masitinib 3 mg/kg/day (1) + riluzole Drug: Masitinib (AB1010)
4.5 mg/kg/day, 3 mg/kg/day

Drug: Riluzole
Experimental: masitinib 4.5 mg/kg/day (2) + riluzole Drug: Masitinib (AB1010)
4.5 mg/kg/day, 3 mg/kg/day

Drug: Riluzole
Placebo Comparator: placebo + riluzole Drug: Riluzole
Drug: Placebo



Primary Outcome Measures :
  1. Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised [ Time Frame: from baseline to week 48 ]

Secondary Outcome Measures :
  1. Change of Forced Vital Capacity (FVC) [ Time Frame: from baseline to each time point (week 4, 8, 12, 24, 36, 48) ]
  2. Combined Assessment of Function and Survival (CAFS) [ Time Frame: from baseline to week 48 ]
  3. Quality of Life [ Time Frame: from baseline to week 48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Main inclusion criteria:

  1. Familial or sporadic ALS
  2. Patient diagnosed with laboratory supported, clinically 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588677


Locations
Spain
Hospital Carlos III
Madrid, Spain, 28029
Sponsors and Collaborators
AB Science

Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT02588677     History of Changes
Other Study ID Numbers: AB10015
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017

Keywords provided by AB Science:
Amyotrophic Lateral Sclerosis (ALS) - masitinib

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Riluzole
Anticonvulsants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents