Trial · NCT02274558

A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

NCT02274558, Phase 3, Completed, Neurocrine Biosciences; results first posted 2017-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia. Trials, record NCT02274558. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02274558

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
NCT number: NCT02274558
Status: Completed
Phases: Phase 3
Enrollment: 234 participants, actual
Lead sponsor: Neurocrine Biosciences
Conditions: Tardive Dyskinesia
Interventions: NBI-98854, Placebo
First posted: 2014-10-24
Last updated: 2017-07-11
Results first posted: 2017-07-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6	Baseline and Week 6	Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by 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	Clinical Global Impression of Change - TD (CGI-TD) at Week 6	Week 6	Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).
Secondary	Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6	Week 6	Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)

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	Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6	Baseline and Week 6	Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression of Change - TD (CGI-TD) at Week 6	Week 6	Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6	Week 6	Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6	Placebo	-0.1	Standard Error 0.4	scores on a scale
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6	Valbenazine 80mg	-3.2	Standard Error 0.4	scores on a scale
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6	Valbenazine 40mg	-1.9	Standard Error 0.4	scores on a scale
Clinical Global Impression of Change - TD (CGI-TD) at Week 6	Placebo	3.2	Standard Error 0.1	scores on a scale
Clinical Global Impression of Change - TD (CGI-TD) at Week 6	Valbenazine 40mg	2.9	Standard Error 0.1	scores on a scale
Clinical Global Impression of Change - TD (CGI-TD) at Week 6	Valbenazine 80mg	2.9	Standard Error 0.1	scores on a scale
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6	Placebo	6		Participants
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6	Valbenazine 40mg	15		Participants
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6	Valbenazine 80mg	28		Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo-Controlled Placebo	78
Overall Study	STARTED	Placebo-Controlled Valbenazine 40mg	76
Overall Study	STARTED	Placebo-Controlled Valbenazine 80mg	80
Overall Study	Included in the Safety Analysis Set	Placebo-Controlled Placebo	76
Overall Study	Included in the Safety Analysis Set	Placebo-Controlled Valbenazine 40mg	72
Overall Study	Included in the Safety Analysis Set	Placebo-Controlled Valbenazine 80mg	79
Overall Study	COMPLETED	Placebo-Controlled Placebo	71
Overall Study	COMPLETED	Placebo-Controlled Valbenazine 40mg	63
Overall Study	COMPLETED	Placebo-Controlled Valbenazine 80mg	71
Overall Study	NOT COMPLETED	Placebo-Controlled Placebo	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events48

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	Dry mouth	Gastrointestinal disorders	Placebo	1	76	1
other	Dry mouth	Gastrointestinal disorders	Valbenazine 40mg	5	72	5
other	Dry mouth	Gastrointestinal disorders	Valbenazine 80mg	0	79	0
other	Somnolence	Nervous system disorders	Placebo	3	76	3
other	Somnolence	Nervous system disorders	Valbenazine 40mg	4	72	4
other	Somnolence	Nervous system disorders	Valbenazine 80mg	4	79	4
other	Suicidal ideation	Psychiatric disorders	Placebo	4	76	4
other	Suicidal ideation	Psychiatric disorders	Valbenazine 40mg	3	72	3
other	Suicidal ideation	Psychiatric disorders	Valbenazine 80mg	1	79	1
serious	Sudden Death	General disorders	Placebo	0	76	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	76
Total, all-cause mortality	Valbenazine 40mg	0	72
Total, all-cause mortality	Valbenazine 80mg	1	79
Total, other adverse events	Placebo	7	76
Total, other adverse events	Valbenazine 40mg	9	72
Total, other adverse events	Valbenazine 80mg	5	79
Total, serious adverse events	Placebo	3	76
Total, serious adverse events	Valbenazine 40mg	4	72
Total, serious adverse events	Valbenazine 80mg	6	79

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28320223	DERIVED	PubMed
28404690	DERIVED	PubMed
29141124	DERIVED	PubMed
30695293	DERIVED	PubMed
31617235	DERIVED	PubMed
40265997	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02274558

GET https://conductscience.org/api/trials/v1/NCT02274558/events?page=2

API reference For AI assistants