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Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

Valbenazine for Cerebral Palsy

Phase 3
Recruiting
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medically confirmed diagnosis of DCP (hyperkinetic movement disorder due to cerebral palsy [CP]) with choreiform movements
Medical conditions are stable and expected to remain stable throughout the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and week 14
Awards & highlights

Study Summary

This trial will compare the effectiveness of valbenazine to a placebo in treating DCP in children and adults aged 6-70.

Who is the study for?
This trial is for people aged 6-70 with dyskinesia due to cerebral palsy, specifically those with choreiform movements. Participants should have stable medical conditions and be able to swallow soft solids or take medication via a gastrostomy tube. It's not for pregnant/breastfeeding individuals, those with other causes of dyskinesia, recent suicidal behavior/ideation, substance abuse, or certain heart conditions.Check my eligibility
What is being tested?
The study is testing the effectiveness of Valbenazine compared to a placebo in improving involuntary movement (chorea) in participants with dyskinesia from cerebral palsy. The goal is to see if Valbenazine can help control these movements better than no treatment.See study design
What are the potential side effects?
Valbenazine may cause side effects such as sleepiness, balance problems (risk of falls), nausea, and potentially long QT syndrome which affects heart rhythm. Not everyone will experience these side effects and they could vary in severity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a movement disorder due to cerebral palsy.
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My health conditions are stable and expected to stay that way during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and week 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 and week 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Total Maximal Chorea (TMC) score of the Unified Huntington Disease Rating Scale (UHDRS) from baseline to the average of the Week 12 and Week 14 assessments
Secondary outcome measures
Caregiver Global Impression of Improvement (CaGI-I) score at Week 14
Change in pain assessment from baseline to Week 14 using the Faces Pain Scale-Revised (FPS-R)
Change in the Clinical Global Impression of Severity (CGI-S) score from baseline to Week 14
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ValbenazineExperimental Treatment1 Intervention
Valbenazine dosed for 14 weeks followed by open-label valbenazine treatment for 32 weeks
Group II: PlaceboPlacebo Group2 Interventions
Placebo dosed for 14 weeks followed by open-label valbenazine treatment for 32 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valbenazine
2018
Completed Phase 4
~880

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,689 Total Patients Enrolled
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,515 Total Patients Enrolled

Media Library

Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05206513 — Phase 3
Dyskinesia Research Study Groups: Placebo, Valbenazine
Dyskinesia Clinical Trial 2023: Valbenazine Highlights & Side Effects. Trial Name: NCT05206513 — Phase 3
Valbenazine (Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05206513 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are Valbenazine's short-term and long-term effects?

"Valbenazine is classified as a phase 3 trial medication, meaning that while there is data supporting its efficacy, there are also multiple rounds of data affirming its safety. As such, our team has given it a score of 3."

Answered by AI

Is this a clinical trial that only young adults can participate in?

"According to the inclusion criteria for this trial, patients must be aged 6 to 70 to be eligible. Out of the 578 total trials, 175 are for patients younger than 18 and 103 are for patients aged 65 and up."

Answered by AI

Could I potentially join this clinical trial as a participant?

"This study is only for patients with cerebral palsy that are between the ages of 6 and 70. Out of the 144 total candidates, how many patients will you be able to screen?"

Answered by AI

Are we currently recruiting for this research project?

"That is correct. The public clinicaltrial.gov website has the most recent information on this trial, which is currently recruiting 144 participants from 5 different locations."

Answered by AI

How many volunteers are helping researchers with this trial?

"That is correct. The clinicaltrials.gov website has the latest information on this trial, which was posted on April 15th, 2022 and was edited October 10th, 2022. This study will have 144 patients total, with 5 different centres participating."

Answered by AI
~30 spots leftby Jun 2025