Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)
Status:
Completed
Trial end date:
2020-12-14
Target enrollment:
Participant gender:
Summary
ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42
SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be
included.
Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for
12 months.
Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral
Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected
patients and may increase survival.
Scale for the Assessment and Rating of Ataxia (SARA) will be used at M0, M6 and M12. To
assess primary criterion, the percentage of patients with a decrease of at least 1 point of
the SARA score between the inclusion visit, and Visit 3 (Months 12) will be calculated.