DyskinesiaPhase 3NCT05206513
Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
A Phase 3 study testing Valbenazine in people with Dyskinesia and Cerebral Palsy, run by Neurocrine Biosciences at 38 sites in 10 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (DCP) with choreiform movements. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Dyskinesia, Cerebral Palsy
- What is being tested?
- Valbenazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 38 sitesin 10 countries
- Study dates
- 15 Apr 2022to 31 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy [CP]) with choreiform movements.
- Medical conditions are stable and expected to remain stable throughout the study.
Who cannot join
- Participants will be excluded from the study if they meet any of the following criteria:
- Are pregnant or breastfeeding.
- Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
- Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
- Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
- Is a substance abuser of any compound.
- Known history of long QT syndrome or cardiac tachyarrhythmia, or clinically significant electrocardiogram (ECG) abnormalities.
Trial locations and contacts
38 sites in 10 countries.
38 sites in 10 countries
United States19 sites
Neurocrine Clinical Site
Aurora, Colorado, 80045
Neurocrine Clinical Site
Baltimore, Maryland, 21205
Neurocrine Clinical Site
Boston, Massachusetts, 02115
Neurocrine Clinical Site
Chicago, Illinois, 60611
Neurocrine Clinical Site
Cincinnati, Ohio, 45229
Neurocrine Clinical Site
Columbus, Ohio, 43205
Neurocrine Clinical Site
Dallas, Texas, 75390-8857
Neurocrine Clinical Site
Farmington Hills, Michigan, 48334
Neurocrine Clinical Site
Fort Worth, Texas, 76104
Neurocrine Clinical Site
Gulf Breeze, Florida, 32561
Neurocrine Clinical Site
Houston, Texas, 77030
Neurocrine Clinical Site
Miami, Florida, 33155
Neurocrine Clinical Site
New York, New York, 10003
Neurocrine Clinical Site
Oklahoma City, Oklahoma, 73120
Neurocrine Clinical Site
Orlando, Florida, 32806
Neurocrine Clinical Site
Portland, Oregon, 97239
Neurocrine Clinical Site
Saint Paul, Minnesota, 55101
Neurocrine Clinical Site
San Diego, California, 92123
Neurocrine Clinical Site
Stamford, Connecticut, 06905
Brazil4 sites
Neurocrine Clinical Site
Brasília, 70684-831
Neurocrine Clinical Site
Curitiba, 80250-060
Neurocrine Clinical Site
Porto Alegre, 90035-001
Neurocrine Clinical Site
Porto Alegre, 90050-170
Poland3 sites
Neurocrine Clinical Site
Gdansk, 80-389
Neurocrine Clinical Site
Krakow, 30-539
Neurocrine Clinical Site
Oświęcim, 32-600
Portugal3 sites
Neurocrine Clinical Site
Lisbon, 1169-045
Neurocrine Clinical Site
Lisbon, 1649-035
Neurocrine Clinical Site
Porto, 4050-651
Argentina2 sites
Neurocrine Clinical Site
Buenos Aires, C1060AAF
Neurocrine Clinical Site
Buenos Aires, C1425EFD
Italy2 sites
Neurocrine Clinical Site
Calambrone, 56128
Neurocrine Clinical Site
Milan, 3. 20162
Spain2 sites
Neurocrine Clinical Site
Barcelona, 08038
Neurocrine Clinical Site
Madrid, 28006
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.
- Conditions
- Dyskinesia, Cerebral Palsy
- Being tested
- Placebo, Valbenazine
- Keywords
- Cerebral Palsy, Vesicular monoamine transporter 2 (VMAT2) inhibitor, Dyskinesia, Neurocrine, Valbenazine, NBI-98854, Dystonia, Chorea, Athetosis, Athetoid cerebral palsy, Choreoathetosis
- Medical subject headings
- Dyskinesias, Cerebral Palsy, Dystonia, Chorea, Athetosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
ValbenazineDrug
Also called NBI-98854
Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment.
Participants may opt to enter an open-label valbenazine treatment extension phase. Receives: Drug: Placebo; Drug: Valbenazine |
| Valbenazine | Experimental | Valbenazine dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment.
Participants may opt to enter an open-label valbenazine treatment extension phase. Receives: Drug: Valbenazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 12 and Week 14
Secondary outcomes (9)
Change in the Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 14
Measured: Baseline, Week 14
Change in the Movement Disorders - Childhood Rating Scale (MD-CRS) Part I Score from Baseline to the Average of the Week 12 and Week 14 Assessments
Measured: Baseline, Week 12 and Week 14
Change in the Total Maximal Dystonia (TMD) Score of the UHDRS from Baseline to the Average of the Week 12 and Week 14 Assessments
Measured: Baseline, Week 12 and Week 14
Patient Global Impression of Improvement (PGI-I) Score at Week 14
Measured: Week 14
Caregiver Global Impression of Improvement (CaGI-I) Score at Week 14
Measured: Week 14
Clinical Global Impression of Improvement (CGI-I) Score at Week 14
Measured: Week 14
Goal Attainment Score at Week 14 Using the Goal Attainment Scale (GAS)
Measured: Week 14
Change in Pain Assessment from Baseline to Week 14 Using the Faces Pain Scale-Revised (FPS-R)
Measured: Baseline, Week 14
Change in the UHDRS Total Motor Score (TMS) from Baseline to the Average of the Week 12 and Week 14 Assessments
Measured: Baseline, Week 12 and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start15 Apr 2022
- Primary completion16 Oct 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyskinesiaStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206513
- Sponsor's protocol ID
- NBI-98854-DCP3018
- Other IDs
- EUCT
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05206513
- Acronym / sponsor ID
- NBI-98854-DCP3018
- Conditions
- Dyskinesia, Cerebral Palsy
- Keywords
- Cerebral Palsy, Vesicular monoamine transporter 2 (VMAT2) inhibitor, Dyskinesia, Neurocrine, Valbenazine, NBI-98854, Dystonia, Chorea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy of valbenazine versus placebo on improving chorea in pediatric and adult participants who have dyskinesia due to cerebral palsy (DCP) with choreiform movements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Drug: ValbenazinePlacebo dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment. Participants may opt to enter an open-label valbenazine treatment extension phase. |
| Valbenazine | Experimental | Drug: ValbenazineValbenazine dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment. Participants may opt to enter an open-label valbenazine treatment extension phase. |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medically confirmed diagnosis of DCP (that is, a hyperkinetic movement disorder due to cerebral palsy [CP]) with choreiform movements.
- Medical conditions are stable and expected to remain stable throughout the study.
Key exclusion criteria (7 listed)
- Are pregnant or breastfeeding.
- Have a clinical diagnosis or history of dyskinesia due to condition other than CP.
- Have inability to swallow soft foods, unless medications can be administered via gastrostomy/gastrojejunostomy tube.
- Have any suicidal behavior or suicidal ideation in the year prior to screening or on Day 1.
- Is a substance abuser of any compound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboCapsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube | Drug | Placebo |
| ValbenazineAlso: NBI-98854Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube | Drug | Placebo, Valbenazine |
Primary outcome
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
Time frame: Baseline, Week 12 and Week 14
9 secondary outcomes
Change in the Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 14
Time frame: Baseline, Week 14
Change in the Movement Disorders - Childhood Rating Scale (MD-CRS) Part I Score from Baseline to the Average of the Week 12 and Week 14 Assessments
Time frame: Baseline, Week 12 and Week 14
Change in the Total Maximal Dystonia (TMD) Score of the UHDRS from Baseline to the Average of the Week 12 and Week 14 Assessments
Time frame: Baseline, Week 12 and Week 14
Patient Global Impression of Improvement (PGI-I) Score at Week 14
Time frame: Week 14
Caregiver Global Impression of Improvement (CaGI-I) Score at Week 14
Time frame: Week 14
Clinical Global Impression of Improvement (CGI-I) Score at Week 14
Time frame: Week 14
Goal Attainment Score at Week 14 Using the Goal Attainment Scale (GAS)
Time frame: Week 14
Change in Pain Assessment from Baseline to Week 14 Using the Faces Pain Scale-Revised (FPS-R)
Time frame: Baseline, Week 14
Change in the UHDRS Total Motor Score (TMS) from Baseline to the Average of the Week 12 and Week 14 Assessments
Time frame: Baseline, Week 12 and Week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
38 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Valbenazine in people with Dyskinesia and Cerebral Palsy, run by Neurocrine Biosciences at 38 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Brazil, Poland, Portugal, Argentina and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, Week 12 and Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.