A

Phase 1

• Conditions: SCA2 patients, both gender, at least 18 years of age; MedDRA version: 20.0Level: PTClassification code 10057660Term: Spinocerebellar ataxiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-001481-23-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-30
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Genetically diagnosed SCA2 (CAG triplet in ATXN2 > or = 33)
- At least 18 years of age
- Signature of informed consent
- Covered by social security
- SARA score > or = 5 and < or = 26
- Age at onset < or = 50 years old

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Treated with riluzole prior to the study
- Hepatotoxic medication
- Hypersensitivity to the active substance or to any of the excipients (Dibasic calcium phosphate anhydrous, Micro crystalline cellulose, Croscarmellose sodium, Colloidal silica anhydrous, Magnesium stearate, Hypromellose, Titanium dioxide (E171) Macrogol 400)
- Hypersensitivity to any of ingredients of placebo (Lactose monohydrate, Micro crystalline cellulose, Colloidal silica, anhydrous, Magnesium stearate, Opadry II HP85F18422 White)
- Serious systemic illnesses or conditions known for enhancing the side-effects of riluzole (i.e., severe cardiac or renal insufficiency (grade 3), hematological (grade 3) and hepatic diseases with serum values of alanine amino transferase levels higher than or equal to twice the normal higher limit or abnormal values of several other hepatic markers (gamma-GT, bilirubine, aspartate aminotransferase levels higher than twice the normal higher limit ) (grade 1),
- Contraindications for MRI examination (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, neuronal stimulator, insulin pump, intravenous catheter, epilepsy, can be subject to form of seizures, metallic contraceptive device, ...)
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified