Status:
COMPLETED
Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spinocerebellar Ataxia Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 w...
Detailed Description
Inherited cerebellar ataxias are genetically heterogeneous neurological disorders. They are characterized by ataxic gait and cerebellar dysarthria that progresses over time with loss of ambulation and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03347344
Start Date
January 17 2018
End Date
December 14 2020
Last Update
June 21 2021
Active Locations (1)
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1
Durr
Paris, France, 75013