Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)

• Status: Completed
• Trial end date: 2020-12-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Riluzole

Criteria

Inclusion Criteria:

• Genetically diagnosed SCA2 (CAG triplet in ATXN2 ≥ 33)

• At least 18 years of age

• Signature of informed consent

• Covered by social security

• SARA score ≥ 5 and ≤ 26

• Age at onset ≤ 50 years old

Exclusion Criteria:

• Treated with riluzole prior to the study

• Hepatotoxic medication

• Hypersensitivity to the active substance or to any of the excipients

• Serious systemic illnesses or conditions known for enhancing the side effects of riluzole

• Contraindications for MRI examination

• Participation in another therapeutic trial (3 months exclusion period)

• Pregnancy or breastfeeding

• Non abstinence or absence of effective contraception for women

• Inability to understand information about the protocol

• Persons deprived of their liberty by judicial or administrative decision

• Adult subject under legal protection or unable to consent

• Other ataxic syndromes than SCA2