Trial · NCT01393600
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
NCT01393600, 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 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder. Trials, record NCT01393600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01393600
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
- NCT number
- NCT01393600
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tardive Dyskinesia
- Interventions
- NBI-98854, NBI-98854, Placebo
- First posted
- 2011-07-13
- Last updated
- 2017-08-10
- Results first posted
- 2017-08-10
Source ClinicalTrials.gov
Registered outcomes2
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 | Day 15 and 29, averaged | 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 - Global Improvement of TD (CGI-TD) | Day 15 and 29, averaged | 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). |
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 | Day 15 and 29, averaged | Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression - Global Improvement of TD (CGI-TD) | Day 15 and 29, averaged | Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15). | units on a scale | MEAN |
| POST_HOC | Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site) | Day 15 and 29, averaged | Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15). | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score | Placebo | 9.9 | Standard Error 0.7 | units on a scale | |
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score | Valbenazine 12.5 mg | 9.1 | Standard Error 1.2 | units on a scale | |
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score | Valbenazine 50 mg | 8.8 | Standard Error 1.2 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | Valbenazine 12.5mg Placebo | 2.2 | Standard Error 0.2 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | Valbenazine 12.5mg | 2.2 | Standard Error 0.2 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | Valbenazine 50mg Placebo | 3.2 | Standard Error 0.3 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | Valbenazine 50mg | 2.6 | Standard Error 0.3 | units on a scale | |
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site) | Placebo | 10.3 | Standard Error 0.9 | units on a scale | |
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site) | Valbenazine 12.5 mg | 9.9 | Standard Error 1.1 | units on a scale | |
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site) | Valbenazine 50 mg | 6.1 | Standard Error 1.2 | units on a scale |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (Day 1 to 14) | STARTED | Placebo, Then Valbenazine 12.5 mg | 9 | |
| Treatment Period 1 (Day 1 to 14) | STARTED | Valbenazine 12.5 mg, Then Placebo | 8 | |
| Treatment Period 1 (Day 1 to 14) | STARTED | Placebo, Then Valbenazine 50 mg | 10 | |
| Treatment Period 1 (Day 1 to 14) | STARTED | Valbenazine 50 mg, Then Placebo | 10 | |
| Treatment Period 1 (Day 1 to 14) | COMPLETED | Placebo, Then Valbenazine 12.5 mg | 9 | |
| Treatment Period 1 (Day 1 to 14) | COMPLETED | Valbenazine 12.5 mg, Then Placebo | 7 | |
| Treatment Period 1 (Day 1 to 14) | COMPLETED | Placebo, Then Valbenazine 50 mg | 9 | |
| Treatment Period 1 (Day 1 to 14) | COMPLETED | Valbenazine 50 mg, Then Placebo | 9 | |
| Treatment Period 1 (Day 1 to 14) | NOT COMPLETED | Placebo, Then Valbenazine 12.5 mg | 0 | |
| Treatment Period 1 (Day 1 to 14) | NOT COMPLETED | Valbenazine 12.5 mg, Then Placebo | 1 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events57
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 | Vision blurred | Eye disorders | Placebo | 0 | 35 | 0 |
| other | Vision blurred | Eye disorders | NBI-98854 12.5 mg | 0 | 17 | 0 |
| other | Vision blurred | Eye disorders | NBI-98854 50 mg | 1 | 19 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 35 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | NBI-98854 12.5 mg | 1 | 17 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | NBI-98854 50 mg | 0 | 19 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 35 | 0 |
| other | Vomiting | Gastrointestinal disorders | NBI-98854 12.5 mg | 1 | 17 | 1 |
| other | Vomiting | Gastrointestinal disorders | NBI-98854 50 mg | 0 | 19 | 0 |
| other | Fatigue | General disorders | Placebo | 2 | 35 | 2 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 35 |
| Total, all-cause mortality | NBI-98854 12.5 mg | 0 | 17 |
| Total, all-cause mortality | NBI-98854 50 mg | 0 | 19 |
| Total, other adverse events | Placebo | 4 | 35 |
| Total, other adverse events | NBI-98854 12.5 mg | 4 | 17 |
| Total, other adverse events | NBI-98854 50 mg | 6 | 19 |
| Total, serious adverse events | Placebo | 0 | 35 |
| Total, serious adverse events | NBI-98854 12.5 mg | 1 | 17 |
| Total, serious adverse events | NBI-98854 50 mg | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01393600
GET https://conductscience.org/api/trials/v1/NCT01393600/flow?page=2