The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

NCT03698331 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: NBI-98854-TD4001
• Study Type: interventional
• Target: 89
• Locations: 2 countries
• Sites: 17

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.

Conditions

Tardive Dyskinesia (TD)

Outcome Measures

Primary Outcomes (1)

• Participants With Withdrawal-Emergent Adverse Events

  A withdrawal-emergent adverse event is an adverse event that begins during the Withdrawal Period.

  3 weeks

Secondary Outcomes (5)

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

  3 weeks

• Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20)

  3 weeks

• Severity of Withdrawal Symptoms as Measured by the Change From Withdrawal Baseline (Week 4) to Week 7 in the Modified Cocaine Selective Severity Assessment (mCSSA)

  7 weeks

• Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score

  Baseline, Week 4, Week 7

• Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale

  Baseline, Week 4, Week 7

Study Arms (2)

Valbenazine

EXPERIMENTAL

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

Drug: Valbenazine; Drug: Placebo oral capsule

Placebo

PLACEBO COMPARATOR

Placebo oral capsules administered once daily for 7 weeks.

Drug: Placebo oral capsule

Interventions

Valbenazine DRUG

vesicular monoamine transporter 2 (VMAT2) inhibitor

Also known as: Ingrezza, NBI-98854

Valbenazine

Placebo oral capsule DRUG

non-active dosage form

Placebo; Valbenazine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
• Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
• 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.
• Be in general good health.
• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

You may not qualify if:

• Have an active, clinically significant unstable medical condition within 1 month before screening.
• Have a known history of substance (drug) dependence, or substance or alcohol abuse.
• Have a significant risk of suicidal or violent behavior.
• Have a known history of neuroleptic malignant syndrome.
• Have a known history of long QT syndrome or cardiac arrhythmia.
• Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
• Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine clinical study.
• Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
• Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
• Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).
• Are currently pregnant or breastfeeding.
• Have HIV or hepatitis B.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (17)

Neurocrine Clinical Site

Anaheim, California, 92804, United States

Location

Neurocrine Clinical Site

Glendale, California, 91206, United States

Location

Neurocrine Clinical Site

Norwalk, California, 90650, United States

Location

Neurocrine Clinical Site

Oceanside, California, 92054, United States

Location

Neurocrine Clinical Site

San Bernardino, California, 92108, United States

Location

Neurocrine Clinical Site

Hialeah, Florida, 33012, United States

Location

Neurocrine Clinical Site

Hialeah, Florida, 33013, United States

Location

Neurocrine Clinical Site

Hialeah, Florida, 33018, United States

Location

Neurocrine Clinical Site

Honolulu, Hawaii, 96817, United States

Location

Neurocrine Clinical Site

Fort Wayne, Indiana, 46804, United States

Location

Neurocrine Clinical Site

Ann Arbor, Michigan, 48105, United States

Location

Neurocrine Clinical Site

Beechwood, Ohio, 44122, United States

Location

Neurocrine Clinical Site

Oklahoma City, Oklahoma, 73112, United States

Location

Neurocrine Clinical Site

Scranton, Pennsylvania, 18503, United States

Location

Neurocrine Clinical Site

DeSoto, Texas, 75115, United States

Location

Neurocrine Clinical Site

Irving, Texas, 75062, United States

Location

Neurocrine Clinical Site

San Juan, 00926, Puerto Rico

Location

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Neurocrine Medical Information
• Organization: Neurocrine Biosciences, Inc.

medinfo@neurocrine.com

877-641-3461

Study Officials

• Chief Medical Officer

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: September 14, 2018
• Primary Completion: April 3, 2019
• Study Completion: April 3, 2019
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (16)