Amyotrophic Lateral Sclerosis
Conditions
Brief summary
Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (ALS).
Interventions
DRUGRiluzole
Sponsors
Sanofi
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of ALS confirmed by the following definition: (a)Probable or Definite Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria(b)Peripheral onset form (limb involvement) or a Bulbar form of ALS with a duration of five years, based on inquiry for the earliest symptoms of the disease * A subject who simultaneously presents with bulbar and peripheral signs at onset of ALS disease should be stratified to the bulbar onset group. The neurologic progression of such subjects matches that of the bulbar onset ALS subjects. * Pulmonary Function: forced vital capacity (FVC) must be 3 60% at study entry. * Females of childbearing potential must be documented to be using acceptable birth control methods such as an IUD or oral contraceptives.
Exclusion criteria
* Previous treatment with riluzole * Tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion * Signs of clinical dementia and/or major psychiatric disorders * Serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival * A multiple conduction block has been shown on nerve conduction studies by electromyogram The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death) | — |
Countries
Canada
Outcome results
None listed