Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06312189 | Long-term Study to Evaluate Safety and Tolerability of Valbenazine in Participants With Chorea Associated With Huntington Disease in Canada | PHASE3 | ENROLLING BY_INVITATION | 7 | — | — | Apr 24, 2024 | Apr 1, 2026 | Apr 9, 2026 | 3 | Canada |
| NCT04400331 | Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease | PHASE3 | ACTIVE NOT_RECRUITING | 154 | — | — | Sep 18, 2020 | Mar 1, 2026 | Dec 24, 2024 | 34 | United States, Canada |
| NCT04102579 | Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease | PHASE3 | COMPLETED | 128 | — | — | Nov 13, 2019 | Oct 26, 2021 | Oct 11, 2023 | 46 | United States, Canada |
The TMC is part of the motor assessment of the UHDRS and measures chorea in 7 different body parts including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. A decrease in TMC scores indicates improvement in chorea symptoms.
| Arm | Type | Description |
|---|---|---|
| Valbenazine | EXPERIMENTAL | Capsule, administered orally once daily. |
| Placebo | PLACEBO_COMPARATOR | Capsule, administered orally once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Valbenazine | DRUG | vesicular monoamine transporter 2 (VMAT2) inhibitor |
| Placebo | DRUG | non-active dosage form |
Key Inclusion Criteria: * Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada. * Partic...