A Phase 3 interventional study of Riluzole and Placebo in Spinocerebellar Ataxia Type 2, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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Among 13 studies in Spinocerebellar Ataxias with a site in France — 5 open to participants now, 7 under way, none of them phase 3. Spinocerebellar Ataxias · France.
Among the 13 studies in Spinocerebellar Ataxias with a site in France, this one is the only one that started in 2018, is the only one in phase 3, and was the 6th registered.
95 studies on the registry are indexed under Spinocerebellar Ataxias; 25 are open to participants now.
Browse Spinocerebellar Ataxias studies →5 of the 13 studies in Spinocerebellar Ataxias with a site in France are open now. Recruiting first, the newest first:
University Hospital, Angers · Sites in France
Ages 18–100 · Healthy volunteers
University Hospital, Montpellier · Sites in France
Ages 18–80
Vico Therapeutics B. V. · Sites in France, Denmark, Germany and 3 more countries
Ages 25–60
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 7+ · Healthy volunteers
Ataxia Study Group · Sites in France, Austria, Belgium and 7 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 16 Spinocerebellar Ataxias studies recruiting now, 8 (50%) set no upper age limit and 3 (19%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 1
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 42 is above the median of 29 across 61 interventional studies indexed under Spinocerebellar Ataxias.
Median enrollment 60 across the 6 interventional studies, 102 across the 7 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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2 of 13 have an industry lead sponsor. The 8 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 3 studies filed under Spinocerebellar Ataxias — fewer than ten, so there is no comparison to draw.
2 of the studies in Spinocerebellar Ataxias with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06672445Arrowhead PharmaceuticalsStudy of ARO-ATXN2 Injection in Adults With Spinocerebellar Ataxia Type 2 | 2026-12 |
| NCT07019558University Hospital, MontpellierOphthalmological Disorders in Dominant Spinal-cerebellar Ataxias | 2027-10 |
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Among the 13 studies in Spinocerebellar Ataxias with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Riluzole
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
Drug: Placebo
50 mg will be administered (per os) twice a day
50 mg will be administered (per os) twice a day
Change in Ataxia symptoms (Scale for the Assessment and Rating of Ataxia (SARA))
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
Time frame: at 12 months.
Change in Ataxia symptoms (Composite Cerebellar Functional Severity (CCFS) score)
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.
Time frame: at 12 months
Change in extracerebellar symptoms (Inventory of Non-Ataxia Signs (INAS))
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
Time frame: at 12 months
12 months survival
To compare survival of the patients between the two treatment groups at 12 months
Time frame: at 12 months
Ran from Jan 2018 to primary completion in Dec 2020, 34 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Riluzole
Assistance Publique - Hôpitaux de Paris →