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(352) 733-0111

Kinect-HD2

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Description

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).

Details

Full study title Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated with Huntington Disease
Protocol number OCR39688
ClinicalTrials.gov ID NCT04400331
Phase Phase 3

Eligibility

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

  1. Had a medically significant illness within 30 days before baseline, or any history of

neuroleptic malignant syndrome

  1. Have a known hypersensitivity to any component of the formulation of valbenazine

  2. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2

inhibitor use within 30 days of baseline

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.