Trial · NCT02405091
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
NCT02405091, Phase 3, Completed, Neurocrine Biosciences; results first posted 2018-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia. Trials, record NCT02405091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02405091
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
- NCT number
- NCT02405091
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 167 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tardive Dyskinesia
- Interventions
- NBI-98854
- First posted
- 2015-04-01
- Last updated
- 2018-11-30
- Results first posted
- 2018-11-30
Source ClinicalTrials.gov
Registered outcomes5
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 | 52 weeks | Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. |
| Secondary | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Baseline and Week 48 | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. |
| Secondary | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the blinded, Central AIMS Video Raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. |
| Secondary | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 | Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. |
| Secondary | Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48 | Week 48 | Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). |
Source ClinicalTrials.gov
Outcomes5
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 | 52 weeks | 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 | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Baseline and Week 48 | 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 | score on a scale | MEAN |
| SECONDARY | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 | 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 | score on a scale | MEAN |
| SECONDARY | Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters | Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52 | 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 | score on a scale | MEAN |
| SECONDARY | Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48 | Week 48 | 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 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group27
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 40mg | 45 | Participants | ||
| Number of Participants Monitored for Long-Term Safety of Valbenazine | Valbenazine 80mg | 107 | Participants | ||
| Number of Participants Monitored for Long-Term Safety of Valbenazine | Valbenazine 80/40mg | 11 | Participants | ||
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Valbenazine 40mg | -10.2 | Standard Error 1.2 | score on a scale | |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Valbenazine 80mg | -11.0 | Standard Error 0.5 | score on a scale | |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters | Valbenazine 80/40mg | -7.2 | Standard Error 2.2 | score on a scale | |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Valbenazine 40mg | At Baseline | 10.2 | Standard Error 0.6 | score on a scale |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Valbenazine 80mg | At Baseline | 10.0 | Standard Error 0.4 | score on a scale |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Valbenazine 80/40mg | At Baseline | 9.3 | Standard Error 0.8 | score on a scale |
| Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters | Valbenazine 40mg | Change from Baseline at Week 8 | -4.5 | Standard Error 0.7 | score on a scale |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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 40mg | 49 | |
| Overall Study | STARTED | Valbenazine 80mg | 107 | |
| Overall Study | STARTED | Valbenazine 80/40mg | 11 | |
| Overall Study | COMPLETED | Valbenazine 40mg | 20 | |
| Overall Study | COMPLETED | Valbenazine 80mg | 74 | |
| Overall Study | COMPLETED | Valbenazine 80/40mg | 9 | |
| Overall Study | NOT COMPLETED | Valbenazine 40mg | 29 | |
| Overall Study | NOT COMPLETED | Valbenazine 80mg | 33 | |
| Overall Study | NOT COMPLETED | Valbenazine 80/40mg | 2 |
Source ClinicalTrials.gov
Adverse events96
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 Through Week 4 | 0 | 163 | |
| other | Urinary tract infection | Infections and infestations | Valbenazine 40mg Week 4 Through Week 52 | 3 | 35 | |
| other | Urinary tract infection | Infections and infestations | Valbenazine 80mg Week 4 Through Week 52 | 9 | 107 | |
| other | Urinary tract infection | Infections and infestations | Valbenazine 80/40mg Week 4 Through Week 52 | 1 | 11 | |
| other | Headache | Nervous system disorders | Valbenazine 40 mg Through Week 4 | 0 | 163 | |
| other | Headache | Nervous system disorders | Valbenazine 40mg Week 4 Through Week 52 | 2 | 35 | |
| other | Headache | Nervous system disorders | Valbenazine 80mg Week 4 Through Week 52 | 6 | 107 | |
| other | Headache | Nervous system disorders | Valbenazine 80/40mg Week 4 Through Week 52 | 0 | 11 | |
| serious | Abdominal pain | Gastrointestinal disorders | Valbenazine 40 mg Through Week 4 | 0 | 163 | |
| serious | Abdominal pain | Gastrointestinal disorders | Valbenazine 40mg Week 4 Through Week 52 | 0 | 35 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valbenazine 40 mg Through Week 4 | 0 | 163 |
| Total, all-cause mortality | Valbenazine 40mg Week 4 Through Week 52 | 0 | 35 |
| Total, all-cause mortality | Valbenazine 80mg Week 4 Through Week 52 | 1 | 107 |
| Total, all-cause mortality | Valbenazine 80/40mg Week 4 Through Week 52 | 0 | 11 |
| Total, other adverse events | Valbenazine 40 mg Through Week 4 | 0 | 163 |
| Total, other adverse events | Valbenazine 40mg Week 4 Through Week 52 | 5 | 35 |
| Total, other adverse events | Valbenazine 80mg Week 4 Through Week 52 | 15 | 107 |
| Total, other adverse events | Valbenazine 80/40mg Week 4 Through Week 52 | 1 | 11 |
| Total, serious adverse events | Valbenazine 40 mg Through Week 4 | 0 | 163 |
| Total, serious adverse events | Valbenazine 40mg Week 4 Through Week 52 | 3 | 35 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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