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Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT03891862
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences

Brief Summary:
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the persistence of effect of valbenazine 40 mg and 80 mg.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia (TD) Drug: Valbenazine Drug: Placebo oral capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Experimental: Valbenazine
Valbenazine oral capsules administered once daily for 8 weeks. Randomization into this arm occurs after open-label treatment with valbenazine once daily for 8 weeks. Total treatment up to 16 weeks.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: Ingrezza, NBI-98854

Placebo Comparator: Placebo
Placebo oral capsules administered once daily for 8 weeks. Randomization into this arm occurs after open-label treatment with valbenazine once daily for 8 weeks. Total treatment up to 16 weeks.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: Ingrezza, NBI-98854

Drug: Placebo oral capsule
non-active dosage form




Primary Outcome Measures :
  1. Severity of dyskinesia as assessed by the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: up to 20 weeks ]
    The AIMS rates 10 items of involuntary movement, each item ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Items assess facial, oral, extremity, and trunk movements, as well as self-awareness of abnormal movements.


Secondary Outcome Measures :
  1. Improvement in quality of life as assessed by the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) [ Time Frame: up to 20 weeks ]
    EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The scores for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
  2. Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
  3. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
  4. Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
  5. Be in general good health.
  6. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria:

  1. Have an active, clinically significant unstable medical condition within 1 month before screening.
  2. Have a known history of substance (drug) dependence, or substance or alcohol abuse.
  3. Have a significant risk of suicidal or violent behavior.
  4. Have been hospitalized for psychiatric disorder within 6 months before Day 1.
  5. Have a known history of neuroleptic malignant syndrome.
  6. Have a known history of long QT syndrome or cardiac arrhythmia.
  7. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
  8. Are currently taking tetrabenazine or deutetrabenazine, or have used valbenazine (INGREZA) within 30 days of screening.
  9. Have received an investigational drug within 30 days before Day 1 or plan to use an investigational drug (other than NBI-98854) during the study.
  10. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  11. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
  12. Are currently pregnant or breastfeeding.
  13. Have HIV or hepatitis B.

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): NCT03891862


Contacts
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Contact: Cheryl Chen 858-617-7744 cechen@neurocrine.com

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Sponsors and Collaborators
Neurocrine Biosciences
Investigators
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Study Director: Chief Medical Officer Chief Medical Officer

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Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT03891862     History of Changes
Other Study ID Numbers: NBI-98854-TD4002
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
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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Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs