Phase 2Not yet recruiting
A Phase 2, open-label trial to investigate the long-term safety of VO659 administered intrathecally in participants with Huntington’s disease and spinocerebellar ataxia type 1 and 3 (VO659-CT03)
- Sponsor
- Vico Therapeutics B.V. (Industry)
- Enrollment
- 55 planned
- Conditions
- Spinocerebellar ataxia types 1, 3 and Huntington's disease
- Interventions
- VO659
- Ages
- adults
- Registry
- CTIS2026-526408-60-00
Full record on the EU Clinical Trials Information System
From the registry
Main objective: To evaluate the long-term safety of IT lumbar bolus administrations of VO659 in participants with clinically manifest HD, SCA1 or SCA3
Primary outcomes
- Incidence and dose relationships of treatment- related AEs, SAEs, AESIs and severe events (NCI- CTCAE Grade 3 or higher), Changes in clinical safety parameters including physical and neurological examinations, vital signs, body weight, ECG, suicidal ideation and behavior risk monitoring by the C-SSR
History
Last registry update
Registered