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| Name | Class |
|---|---|
| Huntington Study Group | NETWORK |
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This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.
After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valbenazine | Experimental | Capsule, administered orally once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valbenazine | Drug | vesicular monoamine transporter 2 (VMAT2) inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to 262 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score | 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 score indicates improvement in chorea. |
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Inclusion Criteria:
Either #1 or #2 must be met for inclusion eligibility.
Have participated in Study NBI-98854-HD3005 and
a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the follow-up visit or early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure related to COVID-19)
Did not participate in Study NBI-98854-HD3005 and
Be able to read and understand English and capable of providing consent to study participation or have a legally authorized representative providing consent and the participant providing assent
Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Birmingham | Alabama | 35294 | United States | ||
| Neurocrine Clinical Site |
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| Label | URL |
|---|---|
| Study website | View source |
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| Up to 262 weeks |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Neurocrine Clinical Site | La Jolla | California | 92037 | United States |
| Neurocrine Clinical Site | Aurora | Colorado | 80045 | United States |
| Neurocrine Clinical Site | Washington D.C. | District of Columbia | 20007 | United States |
| Neurocrine Clinical Site | Boca Raton | Florida | 33486 | United States |
| Neurocrine Clinical Site | Gainesville | Florida | 32608 | United States |
| Neurocrine Clinical Site | Atlanta | Georgia | 30329 | United States |
| Neurocrine Clinical Site | Chicago | Illinois | 60611 | United States |
| Neurocrine Clinical Site | Chicago | Illinois | 60612 | United States |
| Neurocrine Clinical Site | Indianapolis | Indiana | 46202 | United States |
| Neurocrine Clinical Site | Iowa City | Iowa | 52242 | United States |
| Neurocrine Clinical Site | Wichita | Kansas | 67226 | United States |
| Neurocrine Clinical Site | Louisville | Kentucky | 40202 | United States |
| Neurocrine Clinical Site | New Orleans | Louisiana | 70121 | United States |
| Neurocrine Clinical Site | Boston | Massachusetts | 02215 | United States |
| Neurocrine Clinical Site | Charlestown | Massachusetts | 02129 | United States |
| Neurocrine Clinical Site | Ann Arbor | Michigan | 48105 | United States |
| Neurocrine Clinical Site | Omaha | Nebraska | 68105 | United States |
| Neurocrine Clinical Site | Rochester | New York | 14618 | United States |
| Neurocrine Clinical Site | Williamsville | New York | 14221 | United States |
| Neurocrine Clinical Site | Durham | North Carolina | 27705 | United States |
| Neurocrine Clinical Site | Columbus | Ohio | 43221 | United States |
| Neurocrine Clinical Site | Toledo | Ohio | 43614 | United States |
| Neurocrine Clinical Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Neurocrine Clinical Site | Charleston | South Carolina | 29425 | United States |
| Neurocrine Clinical Site | Columbia | South Carolina | 29203 | United States |
| Neurocrine Clinical Site | Greenville | South Carolina | 29615 | United States |
| Neurocrine Clinical Site | Nashville | Tennessee | 37212 | United States |
| Neurocrine Clinical Site | Houston | Texas | 77054 | United States |
| Neurocrine Clinical Site | Burlington | Vermont | 05401 | United States |
| Neurocrine Clinical Site | Vancouver | British Columbia | V6T 2B5 | Canada |
| Neurocrine Clinical Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| Neurocrine Clinical Site | Toronto | Ontario | MK2 1E1 | Canada |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000603978 | valbenazine |
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