Trial · NCT01688037
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study)
NCT01688037, Phase 2, Completed, Neurocrine Biosciences; results first posted 2017-11-08
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 (KINECT Study). Trials, record NCT01688037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01688037
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 (KINECT Study)
- NCT number
- NCT01688037
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tardive Dyskinesia
- Interventions
- NBI-98854, NBI-98854, Placebo
- First posted
- 2012-09-19
- Last updated
- 2017-11-08
- Results first posted
- 2017-11-08
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. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set). |
| Secondary | Clinical Global Impression - Global Improvement of TD (CGI-TD) | 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). The ANOVA analysis of CGI-TD was conducted for the pooled NBI-98854 50+100 mg group and placebo group. |
| Secondary | Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 | Week 2 | 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 Change From Baseline at Week 6 | Baseline and Week 6 | Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at either Week 2 or Week 6). Last observation carried forward (LOCF) imputation method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression - Global Improvement of TD (CGI-TD) | Week 6 | ITT analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at either Week 2 or Week 6). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 | Week 2 | ITT analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at Week 2). | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group7
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 Change From Baseline at Week 6 | Placebo | -2.5 | Standard Error 0.7 | units on a scale | |
| Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 | All Valbenazine | -3.3 | Standard Error 0.7 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | Placebo | 3.2 | Standard Error 0.1 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) | Valbenazine 50mg and Valbenazine 100mg Then 50mg | 3.3 | Standard Error 0.1 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 | Placebo | 3.6 | Standard Error 0.1 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 | Valbenazine 50mg | 3.3 | Standard Error 0.2 | units on a scale | |
| Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2 | Valbenazine 100mg | 3.2 | Standard Error 0.2 | units on a scale |
Source ClinicalTrials.gov
Participant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period (Week 0 to 6) | STARTED | Double-Blind Placebo, Then Open-Label 50mg | 54 | |
| Double-Blind Period (Week 0 to 6) | STARTED | Double-Blind 50mg, Then Open-Label 50mg | 28 | |
| Double-Blind Period (Week 0 to 6) | STARTED | Double-Blind 100mg/50mg, Then Open-Label 50mg | 27 | |
| Double-Blind Period (Week 0 to 6) | COMPLETED | Double-Blind Placebo, Then Open-Label 50mg | 47 | |
| Double-Blind Period (Week 0 to 6) | COMPLETED | Double-Blind 50mg, Then Open-Label 50mg | 25 | |
| Double-Blind Period (Week 0 to 6) | COMPLETED | Double-Blind 100mg/50mg, Then Open-Label 50mg | 21 | |
| Double-Blind Period (Week 0 to 6) | NOT COMPLETED | Double-Blind Placebo, Then Open-Label 50mg | 7 | |
| Double-Blind Period (Week 0 to 6) | NOT COMPLETED | Double-Blind 50mg, Then Open-Label 50mg | 3 | |
| Double-Blind Period (Week 0 to 6) | NOT COMPLETED | Double-Blind 100mg/50mg, Then Open-Label 50mg | 6 | |
| Open-Label Period (Week 6 to 12) | STARTED | Double-Blind Placebo, Then Open-Label 50mg | 47 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events55
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 | Fatigue | General disorders | Double-Blind 50mg | 0 | 28 | 0 |
| other | Fatigue | General disorders | Double-Blind 100mg/50mg | 2 | 27 | 2 |
| other | Fatigue | General disorders | Double-Blind Placebo | 0 | 54 | 0 |
| other | Fatigue | General disorders | Open-Label 50mg | 0 | 93 | 0 |
| other | Fatigue | General disorders | Follow-Up | 0 | 80 | 0 |
| other | Urinary tract infection | Infections and infestations | Double-Blind 50mg | 0 | 28 | 0 |
| other | Urinary tract infection | Infections and infestations | Double-Blind 100mg/50mg | 1 | 27 | 1 |
| other | Urinary tract infection | Infections and infestations | Double-Blind Placebo | 2 | 54 | 2 |
| other | Urinary tract infection | Infections and infestations | Open-Label 50mg | 5 | 93 | 5 |
| other | Urinary tract infection | Infections and infestations | Follow-Up | 0 | 80 | 0 |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-Blind 50mg | 0 | 28 |
| Total, all-cause mortality | Double-Blind 100mg/50mg | 0 | 27 |
| Total, all-cause mortality | Double-Blind Placebo | 0 | 54 |
| Total, all-cause mortality | Open-Label 50mg | 0 | 93 |
| Total, all-cause mortality | Follow-Up | 0 | 80 |
| Total, other adverse events | Double-Blind 50mg | 4 | 28 |
| Total, other adverse events | Double-Blind 100mg/50mg | 3 | 27 |
| Total, other adverse events | Double-Blind Placebo | 2 | 54 |
| Total, other adverse events | Open-Label 50mg | 5 | 93 |
| Total, other adverse events | Follow-Up | 1 | 80 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31617235 | 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/NCT01688037
GET https://conductscience.org/api/trials/v1/NCT01688037/flow?page=2