NCT03347344: ATRIL

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

Completed Phase 3 Last updated 21 June 2021

What this trial tests

Phase 3 trial testing Riluzole in Spinocerebellar Ataxia Type 2 in 42 participants. Completed in 14 December 2020.

Timeline

17 January 2018

Primary endpoint
14 December 2020

14 December 2020

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	42
Start date	17 January 2018
Primary completion	14 December 2020
Estimated completion	14 December 2020
Sites	1 location across France

Drugs / interventions tested

• Riluzole (RILUZOLE) — full drug profile →
• Placebo

Conditions studied

• Spinocerebellar Ataxia Type 2 — all drugs for Spinocerebellar Ataxia Type 2 →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Spinocerebellar Ataxia Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in understanding dominant spinocerebellar ataxias from clinical and genetic points of view.
   Coarelli G, Brice A, Durr A. · · 2018 · cited 34× · PMID 30473770 · DOI 10.12688/f1000research.15788.1
2. Safety and efficacy of riluzole in spinocerebellar ataxia type 2 in France (ATRIL): a multicentre, randomised, double-blind, placebo-controlled trial.
   Coarelli G, Heinzmann A, Ewenczyk C, Fischer C, et al · · 2022 · cited 30× · PMID 35063116 · DOI 10.1016/s1474-4422(21)00457-9
3. Home Aerobic Training for Cerebellar Degenerative Diseases: a Randomized Controlled Trial.
   Barbuto S, Kuo SH, Winterbottom L, Lee S, et al · · 2023 · cited 18× · PMID 35303255 · DOI 10.1007/s12311-022-01394-4
4. HSF1 and Its Role in Huntington's Disease Pathology.
   Kim H, Gomez-Pastor R. · · 2023 · cited 13× · PMID 36396925 · DOI 10.1007/5584_2022_742
5. Longitudinal Changes of Clinical, Imaging, and Fluid Biomarkers in Preataxic and Early Ataxic Spinocerebellar Ataxia Type 2 and 7 Carriers.
   Coarelli G, Dubec-Fleury C, Petit E, Sayah S, et al · · 2024 · cited 10× · PMID 39133883 · DOI 10.1212/wnl.0000000000209749
6. Therapeutic Strategies for Spinocerebellar Ataxia Type 1.
   Kerkhof LMC, van de Warrenburg BPC, van Roon-Mom WMC, Buijsen RAM. · · 2023 · cited 6× · PMID 37238658 · DOI 10.3390/biom13050788
7. Novel Therapeutic Approaches in Inherited Neuropathies: A Systematic Review.
   Hustinx M, Shorrocks AM, Servais L. · · 2023 · cited 4× · PMID 37376074 · DOI 10.3390/pharmaceutics15061626
8. How to improve statistical power in a trial with SCA2 patients using natural history data.
   Tran M, Poulet PE, Petit E, Durr A, et al · · 2026 · PMID 41787540 · DOI 10.1186/s13063-026-09591-w