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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400331
Recruitment Status : Active, not recruiting
First Posted : May 22, 2020
Last Update Posted : November 2, 2023
Sponsor:
Collaborator:
Huntington Study Group
Information provided by (Responsible Party):
Neurocrine Biosciences

Tracking Information
First Submitted Date  ICMJE May 19, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date November 2, 2023
Actual Study Start Date  ICMJE September 18, 2020
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2022)		 Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 156 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2020)		 Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 104 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2022)		 Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score [ Time Frame: Up to 156 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)		 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
Official Title  ICMJE Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chorea, Huntington
Intervention  ICMJE Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: NBI-98854
Study Arms  ICMJE Experimental: Valbenazine
Capsule, administered orally once daily.
Intervention: Drug: Valbenazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 31, 2023)		 154
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2020)		 120
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 (for example, 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 participant providing assent
  4. 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:

  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. Have a known hypersensitivity to any component of the formulation of valbenazine
  13. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04400331
Other Study ID Numbers  ICMJE NBI-98854-HD3006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Neurocrine Biosciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Neurocrine Biosciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Huntington Study Group
Investigators  ICMJE
Study Director: Chief Medical Officer Chief Medical Officer
PRS Account Neurocrine Biosciences
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP