- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347344
Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL) (ATRIL)
Multicenter, Randomized, Double Blind, Placebo Controlled Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Paris, France, 75013
- Durr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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50 mg will be administered (per os) twice a day
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Placebo Comparator: 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
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50 mg will be administered (per os) twice a day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Ataxia symptoms (Scale for the Assessment and Rating of Ataxia (SARA))
Time Frame: at 12 months.
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To compare the proportion of patients with Scale for the Assessment and Rating of Ataxia (SARA) improvement (decrease) of at least one point from baseline to 12 months
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at 12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Ataxia symptoms (Composite Cerebellar Functional Severity (CCFS) score)
Time Frame: at 12 months
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To compare the difference of the CCFS score (Composite Cerebellar Functional Severity Score) from baseline at 12 months.
A decrease is expected in the intervention group.
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at 12 months
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Change in extracerebellar symptoms (Inventory of Non-Ataxia Signs (INAS))
Time Frame: at 12 months
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To compare the difference of the extracerebellar symptoms (INAS, Inventory of Non-Ataxia Signs) by showing decrease in the INAS count from baseline at 12 months
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at 12 months
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12 months survival
Time Frame: at 12 months
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To compare survival of the patients between the two treatment groups at 12 months
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at 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: DURR Alexandra, PU-PH, Assistance Publique Hopitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Neuroprotective Agents
- Protective Agents
- Anticonvulsants
- Riluzole
Other Study ID Numbers
- P160927J
- 2017-001481-23 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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