CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 89 enrolled
Drug / intervention
Valbenazine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03698331
NCT03698331Phase 4Completed
CompareCT.gov

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

Neurocrine Biosciences·interventional·Posted Oct 9, 2018·Updated Jun 4, 2020

In Brief

A Phase 4 clinical trial evaluating Valbenazine and Placebo oral capsule for Tardive Dyskinesia (TD). Completed, enrolled 89 participants across 17 sites in 2 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTardive Dyskinesia (TD)
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 9, 2018
Enrollment StartSep 14, 2018
Primary CompletionApr 3, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.7 years ago

Interventions

Valbenazinedrug

vesicular monoamine transporter 2 (VMAT2) inhibitor

Placebo oral capsuledrug

non-active dosage form