Trials / Terminated
TerminatedNCT04617847
Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients With Huntington's Disease
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Wave Life Sciences Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WVE-120101 | WVE-120101 is a stereopure antisense oligonucleotide (ASO). It is administered monthly via intrathecal injection. |
Timeline
- Start date
- 2020-04-13
- Primary completion
- 2021-05-03
- Completion
- 2021-05-03
- First posted
- 2020-11-05
- Last updated
- 2022-02-09
- Results posted
- 2022-02-09
Locations
18 sites across 7 countries: Australia, Canada, Denmark, France, Germany, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04617847. Inclusion in this directory is not an endorsement.