Trial · NCT03444038
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
NCT03444038, Phase 2, Completed, Neurocrine Biosciences; results first posted 2022-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome. Trials, record NCT03444038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03444038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
- NCT number
- NCT03444038
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tourette Syndrome
- Interventions
- Valbenazine
- First posted
- 2018-02-23
- Last updated
- 2022-02-23
- Results first posted
- 2022-02-23
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through Week 24 | A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. All qualifying TEAE are reported regardless of threshold. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through Week 24 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Valbenazine | 71 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valbenazine | 85 | |
| Overall Study | COMPLETED | Valbenazine | 56 | |
| Overall Study | NOT COMPLETED | Valbenazine | 29 |
Source ClinicalTrials.gov
Adverse events11
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 | Abdominal pain upper | Gastrointestinal disorders | Valbenazine | 5 | 85 | |
| other | Nausea | Gastrointestinal disorders | Valbenazine | 9 | 85 | |
| other | Fatigue | General disorders | Valbenazine | 11 | 85 | |
| other | Irritability | General disorders | Valbenazine | 8 | 85 | |
| other | Headache | Nervous system disorders | Valbenazine | 9 | 85 | |
| other | Sedation | Nervous system disorders | Valbenazine | 10 | 85 | |
| other | Somnolence | Nervous system disorders | Valbenazine | 17 | 85 | |
| other | Depression | Psychiatric disorders | Valbenazine | 5 | 85 | |
| serious | Infected bites | Infections and infestations | Valbenazine | 1 | 85 | |
| serious | Cognitive disorder | Nervous system disorders | Valbenazine | 1 | 85 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valbenazine | 0 | 85 |
| Total, other adverse events | Valbenazine | 50 | 85 |
| Total, serious adverse events | Valbenazine | 3 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33682568 | BACKGROUND |
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/NCT03444038
GET https://conductscience.org/api/trials/v1/NCT03444038/registered