Trial · NCT01733121

NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

NCT01733121, Phase 2, Completed, Neurocrine Biosciences; results first posted 2017-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia. Trials, record NCT01733121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01733121

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Trial

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

Title: NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
NCT number: NCT01733121
Status: Completed
Phases: Phase 2
Enrollment: 102 participants, actual
Lead sponsor: Neurocrine Biosciences
Conditions: Tardive Dyskinesia
Interventions: NBI-98854, NBI-98854, Placebo
First posted: 2012-11-26
Last updated: 2017-08-10
Results first posted: 2017-08-10

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	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 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	AIMS Dyskinesia Total Score Change From Baseline at Week 6	Week 6	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.

Source ClinicalTrials.gov

Outcomes4

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	Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 \[for subjects in the NBI-98854 group\], and had no efficacy-related important protocol deviations)	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6	Week 6	Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 \[for subjects in the NBI-98854 group\], and had no efficacy-related important protocol deviations)	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	AIMS Dyskinesia Total Score Change From Baseline at Week 6	Week 6	Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6	Week 6	Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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	-0.3	Standard Error 1.1	units on a scale
Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6	Valbenazine	-3.4	Standard Error 1.2	units on a scale
Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6	Placebo	3.1	95% Confidence Interval 2.5 to 3.6	units on a scale
Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6	Valbenazine	2.2	95% Confidence Interval 1.6 to 2.9	units on a scale
AIMS Dyskinesia Total Score Change From Baseline at Week 6	Placebo	-0.2	95% Confidence Interval -2.4 to 2.0	units on a scale
AIMS Dyskinesia Total Score Change From Baseline at Week 6	NBI-98854	-2.6	95% Confidence Interval -4.9 to -0.3	units on a scale
Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6	Placebo	3.1	95% Confidence Interval 2.5 to 3.6	units on a scale
Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6	Valbenazine	2.2	95% Confidence Interval 1.7 to 2.8	units on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Double-Blind Period (Week 0 to 6)	STARTED	Placebo	51
Double-Blind Period (Week 0 to 6)	STARTED	Valbenazine	51
Double-Blind Period (Week 0 to 6)	COMPLETED	Placebo	44
Double-Blind Period (Week 0 to 6)	COMPLETED	Valbenazine	46
Double-Blind Period (Week 0 to 6)	NOT COMPLETED	Placebo	7
Double-Blind Period (Week 0 to 6)	NOT COMPLETED	Valbenazine	5
Follow-Up Period (Week 6 to 8)	STARTED	Placebo	44
Follow-Up Period (Week 6 to 8)	STARTED	Valbenazine	46
Follow-Up Period (Week 6 to 8)	COMPLETED	Placebo	44
Follow-Up Period (Week 6 to 8)	COMPLETED	Valbenazine	46

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events24

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	Constipation	Gastrointestinal disorders	Placebo	3	49	3
other	Constipation	Gastrointestinal disorders	Valbenazine	2	51	2
other	Dry mouth	Gastrointestinal disorders	Placebo	0	49	0
other	Dry mouth	Gastrointestinal disorders	Valbenazine	3	51	3
other	Nausea	Gastrointestinal disorders	Placebo	2	49	2
other	Nausea	Gastrointestinal disorders	Valbenazine	3	51	3
other	Vomiting	Gastrointestinal disorders	Placebo	0	49	0
other	Vomiting	Gastrointestinal disorders	Valbenazine	3	51	3
other	Fatigue	General disorders	Placebo	2	49	2
other	Fatigue	General disorders	Valbenazine	5	51	5

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	49
Total, all-cause mortality	Valbenazine	0	51
Total, other adverse events	Placebo	11	49
Total, other adverse events	Valbenazine	16	51
Total, serious adverse events	Placebo	2	49
Total, serious adverse events	Valbenazine	0	51

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28404690	DERIVED	PubMed
31617235	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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Valbenazine vs Placebo: deaths from any cause	Trial comparisons
Valbenazine vs Placebo: serious adverse events	Trial comparisons

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/NCT01733121

GET https://conductscience.org/api/trials/v1/NCT01733121/events?page=2

API reference For AI assistants