The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

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Brief Title

The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

Official Title

A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Participants With Withdrawal-Emergent Adverse Events

Secondary Outcome

 Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20)

Condition

Tardive Dyskinesia (TD)

Intervention

Valbenazine

Study Arms / Comparison Groups

 Valbenazine
Description:  Valbenazine or placebo oral capsules administered once daily for 7 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

89

Start Date

September 14, 2018

Completion Date

April 3, 2019

Primary Completion Date

April 3, 2019

Eligibility 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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Chief Medical Officer, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT03698331

Organization ID

NBI-98854-TD4001


Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences


Study Sponsor

Chief Medical Officer, Study Director, Chief Medical Officer


Verification Date

May 2020