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The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

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ClinicalTrials.gov Identifier: NCT03698331
Recruitment Status : Completed
First Posted : October 8, 2018
Last Update Posted : July 17, 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 potential for clinical dependence and withdrawal symptoms associated with valbenazine.

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)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
Actual Study Start Date : September 14, 2018
Actual Primary Completion Date : April 3, 2019
Actual Study Completion Date : April 3, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine

Arm Intervention/treatment
Experimental: Valbenazine
Valbenazine or placebo oral capsules administered once daily for 7 weeks.
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Name: Ingrezza, NBI-98854

Drug: Placebo oral capsule
non-active dosage form

Placebo Comparator: Placebo
Placebo oral capsules administered once daily for 7 weeks.
Drug: Placebo oral capsule
non-active dosage form




Primary Outcome Measures :
  1. Number of Participants with Withdrawal-Related Adverse Events [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Percentage of Subjects who Experience Significant Withdrawal Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20) [ Time Frame: 7 weeks ]
    The PWC-20 is a validated 20-item physician-rated survey that assesses the severity of potential symptoms of withdrawal. Items are rated on a scale from 0 to 3, with total scores ranging from 0 to 60. Significant withdrawal symptoms is defined by 5 new symptoms of moderate or severe degree or a worsening of symptoms by 2 points on the PWC-20 scale during Weeks 5 to 7 compared with Week 4

  2. Severity of Withdrawal Symptoms as Measured by the Modified Cocaine Selective Severity Assessment (mCSSA) [ Time Frame: 7 weeks ]
    The mCSSA is an 18-item survey based on symptoms commonly associated with early cocaine abstinence, including depression, fatigue, anhedonia, anxiety, irritability, sleep disturbance, and inability to concentrate. Items are rated on scales of 0 to 7 or 0 to 8, with separate scale descriptions for each item. The scale has been modified to be specific to study drug (valbenazine or placebo) instead of cocaine.

  3. Overall improvement of TD symptoms as measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) [ Time Frame: 7 weeks ]
  4. Overall improvement of TD symptoms as measured by the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) [ Time Frame: 7 weeks ]


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Ages Eligible for Study:   18 Years to 65 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 a known history of neuroleptic malignant syndrome.
  5. Have a known history of long QT syndrome or cardiac arrhythmia.
  6. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
  7. Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine clinical study.
  8. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
  9. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
  10. Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
  11. Are currently pregnant or breastfeeding.
  12. 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): NCT03698331


Locations
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United States, California
Neurocrine Clinical Site
Anaheim, California, United States, 92804
Neurocrine Clinical Site
Glendale, California, United States, 91206
Neurocrine Clinical Site
Norwalk, California, United States, 90650
Neurocrine Clinical Site
Oceanside, California, United States, 92054
Neurocrine Clinical Site
San Bernardino, California, United States, 92108
United States, Florida
Neurocrine Clinical Site
Hialeah, Florida, United States, 33012
Neurocrine Clinical Site
Hialeah, Florida, United States, 33013
Neurocrine Clinical Site
Hialeah, Florida, United States, 33018
United States, Hawaii
Neurocrine Clinical Site
Honolulu, Hawaii, United States, 96817
United States, Indiana
Neurocrine Clinical Site
Fort Wayne, Indiana, United States, 46804
United States, Michigan
Neurocrine Clinical Site
Ann Arbor, Michigan, United States, 48105
United States, Ohio
Neurocrine Clinical Site
Beechwood, Ohio, United States, 44122
United States, Oklahoma
Neurocrine Clinical Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Neurocrine Clinical Site
Scranton, Pennsylvania, United States, 18503
United States, Texas
Neurocrine Clinical Site
DeSoto, Texas, United States, 75115
Neurocrine Clinical Site
Irving, Texas, United States, 75062
Puerto Rico
Neurocrine Clinical Site
San Juan, Puerto Rico, 00926
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: NCT03698331     History of Changes
Other Study ID Numbers: NBI-98854-TD4001
First Posted: October 8, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 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
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Dyskinesias
Tardive Dyskinesia
Substance Withdrawal Syndrome
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Tetrabenazine
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs