Trial · NCT02736955
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
NCT02736955, Phase 3, Completed, Neurocrine Biosciences; results first posted 2018-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia. Trials, record NCT02736955. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02736955
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
- NCT number
- NCT02736955
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 161 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tardive Dyskinesia
- Interventions
- Valbenazine
- First posted
- 2016-04-13
- Last updated
- 2018-12-19
- Results first posted
- 2018-12-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Monitored for Long-term Safety of Valbenazine | 60 weeks | Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. |
| Secondary | Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Baseline and Weeks 12, 24, 36, 48, and 60 | Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= "Normal, not at all ill" to 7= "Among the most extremely ill patient"). A clinical response was defined as a CGI-TD-S score equal to "1" or "2." |
| Secondary | Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) | Baseline and Weeks 12, 24, 36, 48, and 60 | Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to "1" or "2." |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Monitored for Long-term Safety of Valbenazine | 60 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Baseline and Weeks 12, 24, 36, 48, and 60 | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ) | Baseline and Weeks 12, 24, 36, 48, and 60 | Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Monitored for Long-term Safety of Valbenazine | Valbenazine 40 mg | 35 | Participants | ||
| Number of Participants Monitored for Long-term Safety of Valbenazine | Valbenazine 80 mg | 117 | Participants | ||
| Number of Participants Monitored for Long-term Safety of Valbenazine | Valbenazine 40/80 mg | 8 | Participants | ||
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 40 mg | Baseline | 2 | Participants | |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 80 mg | Baseline | 21 | Participants | |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 40/80 mg | Baseline | 0 | Participants | |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 40 mg | Week 12 | 15 | Participants | |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 80 mg | Week 12 | 56 | Participants | |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 40/80 mg | Week 12 | 3 | Participants | |
| Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale | Valbenazine 40 mg | Week 24 | 11 | Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valbenazine 40 mg | 36 | |
| Overall Study | STARTED | Valbenazine 80 mg | 117 | |
| Overall Study | STARTED | Valbenazine 40/80 mg | 8 | |
| Overall Study | COMPLETED | Valbenazine 40 mg | 29 | |
| Overall Study | COMPLETED | Valbenazine 80 mg | 103 | |
| Overall Study | COMPLETED | Valbenazine 40/80 mg | 6 | |
| Overall Study | NOT COMPLETED | Valbenazine 40 mg | 7 | |
| Overall Study | NOT COMPLETED | Valbenazine 80 mg | 14 | |
| Overall Study | NOT COMPLETED | Valbenazine 40/80 mg | 2 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Urinary tract infection | Infections and infestations | Valbenazine 40 mg | 1 | 35 | |
| other | Urinary tract infection | Infections and infestations | Valbenazine 80 mg | 6 | 117 | |
| other | Urinary tract infection | Infections and infestations | Valbenazine 40/80 mg | 0 | 8 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Valbenazine 40 mg | 2 | 35 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Valbenazine 80 mg | 4 | 117 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Valbenazine 40/80 mg | 0 | 8 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Valbenazine 40 mg | 2 | 35 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Valbenazine 80 mg | 3 | 117 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Valbenazine 40/80 mg | 1 | 8 | |
| other | Somnolence | Nervous system disorders | Valbenazine 40 mg | 1 | 35 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valbenazine 40 mg | 0 | 35 |
| Total, all-cause mortality | Valbenazine 80 mg | 3 | 117 |
| Total, all-cause mortality | Valbenazine 40/80 mg | 1 | 8 |
| Total, other adverse events | Valbenazine 40 mg | 6 | 35 |
| Total, other adverse events | Valbenazine 80 mg | 23 | 117 |
| Total, other adverse events | Valbenazine 40/80 mg | 6 | 8 |
| Total, serious adverse events | Valbenazine 40 mg | 3 | 35 |
| Total, serious adverse events | Valbenazine 80 mg | 11 | 117 |
| Total, serious adverse events | Valbenazine 40/80 mg | 2 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32419679 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02736955
GET https://conductscience.org/api/trials/v1/NCT02736955/results?page=2