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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2020-12-14

Brief Summary

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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.

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Detailed Description

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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 speech. The mutations by expansions of CAG triplets in the genes ATXN1 (SCA1), ATXN 2 (SCA2), 3 (SCA3), CACNA1A (SCA6), ATXN 7 (SCA7), and TBP (SCA17) are responsible for 50% of hereditary forms There is no curative or preventive treatment. This phase III study is a multi-centric, double-blind randomized, two-arm controlled study (one group with 50 mg Riluzole twice a day versus one group with placebo), to measure the efficacy of treatment with riluzole in SCA2 patients during 12 months. Amelioration is defined by a 1 point decrease of the SARA score.

Conditions

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Spinocerebellar Ataxia Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-centric, double-blind randomized, two-arm controlled study (one group with 50 mg riluzole twice a day versus one group with placebo), during one year

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Treatments will be presented in numbered boxes, labeled for this study according to the Good Manufacturing Practices by the General Agency of Equipment and Health Products (AGEPS).

Each numbered box will consist of 6 months of treatment: 20 blister packs of 20 active or placebo tablets

Study Groups

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RILUZOLE

Riluzole PMCS 50 mg is presented as a round, biconvex, 8 mm diameter nearly white film-coated tablet. The tablets will be held under a blister of 20 tablets.

Group Type EXPERIMENTAL

Riluzole

Intervention Type DRUG

50 mg will be administered (per os) twice a day

PLACEBO

The placebo PMCS 50 mg is presented as a round, biconvex, 8 mm diameter nearly white film-coated tablet matching the appearance of the Riluzole used in this study

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

50 mg will be administered (per os) twice a day

Interventions

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Riluzole

50 mg will be administered (per os) twice a day

Intervention Type DRUG

Placebo

50 mg will be administered (per os) twice a day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No