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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02588677
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

Study Description
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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 (4.5) Drug: Riluzole Drug: Placebo Drug: Masitinib (3.0) 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.

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 Design
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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 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Riluzole

Arms and Interventions
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Arm Intervention/treatment
Experimental: Masitinib (3.0) & Riluzole
masitinib 3 mg/kg/day + riluzole
 Drug: Riluzole
Other Name: Rilutek

Drug: Masitinib (3.0)
3 mg/kg/day
Other Name: AB1010
Experimental: Masitinib (4.5) & Riluzole
masitinib 4.5 mg/kg/day (2) + riluzole
 Drug: Masitinib (4.5)
4.5 mg/kg/day
Other Name: AB1010

Drug: Riluzole
Other Name: Rilutek
Placebo Comparator: Placebo & Riluzole
Matched placebo
 Drug: Riluzole
Other Name: Rilutek

Drug: Placebo
Other Name: Placebo Oral Tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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 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

Contacts and Locations
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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
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Spain
Hospital Carlos III
Madrid, Spain, 28029
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Jesus S Mora, MD Unidad de ELA, Hospital San Rafael, c/ Serrano, 199, 28016 Madrid, Spain
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT02588677    
Other Study ID Numbers: AB10015
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AB Science:
Amyotrophic Lateral Sclerosis (ALS) - masitinib
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
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