NCT03660917 Riluzole in Patients With Spinocerebellar Ataxia Type 7
| NCT ID | NCT03660917 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | S. Andrea Hospital |
| Condition | SCA7 |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 34 participants in total. It began in 2021-06-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spinocerebellar ataxia type 7 (SCA7) belongs to the dominant forms of inherited cerebellar ataxias (CA), being one of the rarest form. SCA7 has no therapeutic options, so that the relentless course, the important visual deficit that accompanies CA, and the possibility of disease development in childhood are pressing unmet needs. The investigators published encouraging data on riluzole in inherited CA other than SCA7. These results prompted off-label use of riluzole in single cases of SCA7 in Italy and United States, suggesting possible efficacy of the drug in this condition.
Eligibility Criteria
Inclusion Criteria: * positive genetic test for SCA7. Exclusion Criteria: * cardiac arrhythmias; * haematologic diseases; * hepatic diseases with serum values of alanine aminotransferase, aspartate aminotransferase or bilirubin \> 1·5 times above normal limit; * pregnancy (women of childbearing potential agreed to use contraception); * breastfeeding.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03660917 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying SCA7. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03660917 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03660917 currently recruiting?
Yes, NCT03660917 is actively recruiting participants. Contact the research team at silvia.romano@uniroma1.it for enrollment information.
Where is the NCT03660917 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT03660917 clinical trial?
NCT03660917 is sponsored by S. Andrea Hospital. The trial plans to enroll 34 participants.