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

ConditionAmyotrophic Lateral Sclerosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-81
SponsorAB Science

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria

Patient with a familial or sporadic ALS

ALS disease duration from diagnosis no longer than 24 months at the screening visit

Patient treated with a stable dose of riluzole (100 mg/day) for at least 12 weeks days prior to the baseline visit

Disqualifiers

Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results

Patient with a FVC < 60% predicted normal value for gender, height, and age at screening and baseline

Pregnant, or nursing female patient

Trial design

Design model

Parallel

Treatments tested in this trial

  • Masitinib (6.0)

    Drug

    Masitinib (titration to 6.0 mg/kg/day)

  • Riluzole

    Drug

    Riluzole 50 mg tablet, treatment per os

  • Placebo

    Drug

    treatment per os

  • Masitinib (4.5)

    Drug

    Masitinib (titration to 4.5 mg/kg/day)

Treatment groups

495 Participants
are divided into 3 treatment groups
Group A: Masitinib (4.5) & RiluzoleExperimental treatment 2 interventions
Group B: Masitinib (6.0) & RiluzoleExperimental treatment 2 interventions
Group C: Placebo & RiluzolePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

ALSFRS-R

Change in Amyotrophic Lateral Sclerosis functional rating scale (ALSFRS)-Revised.

Time frame
48 weeks

Secondary outcomes

1

ALSAQ-40

Change in ALS quality of life patient questionnaire (ALSAQ-40)

Time frame
48 weeks
2

PFS

Progression free survival (PFS) is defined as the time from randomization to progression (decline of more than 9 points in ALSFRS-R score from baseline) or death

Time frame
From day of randomization to disease progression or death, assessed for a maximum of 36 months
3

FVC

Change in Forced Vital Capacity (FVC)

Time frame
48 weeks
4

HHD

Change in evaluation of upper- and lower-limb muscle strength using hand-held dynamometry (HHD)

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AB Science

Lead sponsor

Source ClinicalTrials.gov
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