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The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

NCT03698331 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-06-04

Study results available
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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)

Interventions

DRUG

Valbenazine

vesicular monoamine transporter 2 (VMAT2) inhibitor

DRUG

Placebo oral capsule

non-active dosage form

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-14
Primary Completion
2019-04-03
Completion
2019-04-03
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03698331 on ClinicalTrials.gov