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Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400331
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : April 11, 2022
Sponsor:
Collaborator:
Huntington Study Group
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide subjects continued access to valbenazine for the treatment of chorea associated with Huntington disease.

Condition or disease Intervention/treatment Phase
Chorea, Huntington Drug: Valbenazine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
Actual Study Start Date : September 18, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
Experimental: Valbenazine
Capsule, administered orally once daily.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: NBI-98854




Primary Outcome Measures :
  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 104 weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score [ Time Frame: Up to 104 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Either #1 or #2 must be met for inclusion eligibility.

  1. 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 (eg, site closure related to COVID-19)

  2. Did not participate in Study NBI-98854-HD3005 and

    1. Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
    2. Be able to walk, with or without the assistance of a person or device
  3. 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 subject providing assent
  4. Subjects 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:

  1. Have difficulty swallowing
  2. Are currently pregnant or breastfeeding
  3. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
  4. Have an unstable or serious medical or psychiatric illness
  5. Have a significant risk of suicidal behavior
  6. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
  7. Have received gene therapy at any time
  8. Have received an investigational drug in a clinical study (other than valbenazine) within 30 days before the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
  9. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
  10. Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
  11. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
  12. For subjects who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400331


Contacts
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Contact: Neurocrine Medical Information Call Center 877-641-3461 medinfo@neurocrine.com

Locations
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United States, Alabama
Neurocrine Clinical Site Recruiting
Birmingham, Alabama, United States, 35294
United States, Arkansas
Neurocrine Clinical Site Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Neurocrine Clinical Site Recruiting
La Jolla, California, United States, 92037
United States, Colorado
Neurocrine Clinical Site Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Neurocrine Clinical Site Recruiting
Washington, District of Columbia, United States, 20007
United States, Florida
Neurocrine Clinical Site Recruiting
Boca Raton, Florida, United States, 33431
Neurocrine Clinical Site Recruiting
Gainesville, Florida, United States, 32608
United States, Georgia
Neurocrine Clinical Site Recruiting
Atlanta, Georgia, United States, 30329
United States, Illinois
Neurocrine Clinical Site Recruiting
Chicago, Illinois, United States, 60611
Neurocrine Clinical Site Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Neurocrine Clinical Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
Neurocrine Clinical Site Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Neurocrine Clinical Site Recruiting
Wichita, Kansas, United States, 67226
United States, Kentucky
Neurocrine Clinical Site Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Neurocrine Clinical Site Recruiting
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Neurocrine Clinical Site Recruiting
Boston, Massachusetts, United States, 02215
Neurocrine Clinical Site Recruiting
Charlestown, Massachusetts, United States, 02129
United States, Michigan
Neurocrine Clinical Site Recruiting
Ann Arbor, Michigan, United States, 48105
United States, Nebraska
Neurocrine Clinical Site Recruiting
Omaha, Nebraska, United States, 68105
United States, New York
Neurocrine Clinical Site Recruiting
Rochester, New York, United States, 14618
Neurocrine Clinical Site Recruiting
Williamsville, New York, United States, 14221
United States, North Carolina
Neurocrine Clinical Site Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Neurocrine Clinical Site Recruiting
Columbus, Ohio, United States, 43221
Neurocrine Clinical Site Recruiting
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Neurocrine Clinical Site Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Neurocrine Clinical Site Recruiting
Charleston, South Carolina, United States, 29425
Neurocrine Clinical Site Recruiting
Columbia, South Carolina, United States, 29203
Neurocrine Clinical Site Recruiting
Greenville, South Carolina, United States, 29615
United States, Tennessee
Neurocrine Clinical Site Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Neurocrine Clinical Site Recruiting
Houston, Texas, United States, 77054
United States, Vermont
Neurocrine Clinical Site Recruiting
Burlington, Vermont, United States, 05401
Canada, British Columbia
Neurocrine Clinical Site Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Neurocrine Clinical Site Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Neurocrine Clinical Site Recruiting
Toronto, Ontario, Canada, MK2 1E1
Sponsors and Collaborators
Neurocrine Biosciences
Huntington Study Group
Investigators
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Study Director: Chief Medical Officer Chief Medical Officer
Additional Information:
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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT04400331    
Other Study ID Numbers: NBI-98854-HD3006
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Huntington Disease
Chorea
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations