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Masitinib in Combination With Riluzole for 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 : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
AB Science

Tracking Information
First Submitted Date  ICMJE October 20, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date December 17, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 5, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
Change from baseline to week 48 in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised [ Time Frame: From baseline to week 48 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised [ Time Frame: up to 48 weeks ]
  • Overall survival (OS) [ Time Frame: up to 48 weeks ]
  • Forced vital capacity (FVC) [ Time Frame: Up to 48 weeks ]
  • Quality of Life [ Time Frame: Up to 48 weeks ]
  • Safety profile [ Time Frame: Up to 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE
  • Drug: Masitinib (4.5)
    4.5 mg/kg/day
    Other Name: AB1010
  • Drug: Riluzole
    Other Name: Rilutek
  • Drug: Placebo
    Other Name: Placebo Oral Tablet
  • Drug: Masitinib (3.0)
    3 mg/kg/day
    Other Name: AB1010
Study Arms  ICMJE
  • Experimental: Masitinib (3.0) & Riluzole
    masitinib 3 mg/kg/day + riluzole
    Interventions:
    • Drug: Riluzole
    • Drug: Masitinib (3.0)
  • Experimental: Masitinib (4.5) & Riluzole
    masitinib 4.5 mg/kg/day (2) + riluzole
    Interventions:
    • Drug: Masitinib (4.5)
    • Drug: Riluzole
  • Placebo Comparator: Placebo & Riluzole
    Matched placebo
    Interventions:
    • Drug: Riluzole
    • Drug: Placebo
Publications * Mora JS, Bradley WG, Chaverri D, Hernández-Barral M, Mascias J, Gamez J, Gargiulo-Monachelli GM, Moussy A, Mansfield CD, Hermine O, Ludolph AC. Long-term survival analysis of masitinib in amyotrophic lateral sclerosis. Ther Adv Neurol Disord. 2021 Jul 19;14:17562864211030365. doi: 10.1177/17562864211030365. eCollection 2021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
394
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
381
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 5, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02588677
Other Study ID Numbers  ICMJE AB10015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AB Science
Study Sponsor  ICMJE AB Science
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jesus S Mora, MD Unidad de ELA, Hospital San Rafael, c/ Serrano, 199, 28016 Madrid, Spain
PRS Account AB Science
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP