Trial · NCT02879578
Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
NCT02879578, Phase 2, Completed, Neurocrine Biosciences; results first posted 2021-04-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome. Trials, record NCT02879578. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02879578
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome
- NCT number
- NCT02879578
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tourette Syndrome
- Interventions
- Valbenazine
- First posted
- 2016-08-25
- Last updated
- 2021-04-29
- Results first posted
- 2021-04-29
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Frequency of Treatment-emergent Adverse Events (TEAEs) | Baseline through Week 28 | 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. |
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 | Frequency of Treatment-emergent Adverse Events (TEAEs) | Baseline through Week 28 | Safety analysis set, which includes all participants who received at least one dose of study drug and have any postbaseline data. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Frequency of Treatment-emergent Adverse Events (TEAEs) | Valbenazine (Children) | 20 | Participants | ||
| Frequency of Treatment-emergent Adverse Events (TEAEs) | Valbenazine (Adolescents) | 29 | Participants | ||
| Frequency of Treatment-emergent Adverse Events (TEAEs) | Valbenazine (Adults) | 68 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Valbenazine (Children) | 33 | |
| Overall Study | STARTED | Valbenazine (Adolescents) | 41 | |
| Overall Study | STARTED | Valbenazine (Adults) | 81 | |
| Overall Study | Safety Analysis Set | Valbenazine (Children) | 33 | |
| Overall Study | Safety Analysis Set | Valbenazine (Adolescents) | 40 | |
| Overall Study | Safety Analysis Set | Valbenazine (Adults) | 79 | |
| Overall Study | COMPLETED | Valbenazine (Children) | 23 | |
| Overall Study | COMPLETED | Valbenazine (Adolescents) | 32 | |
| Overall Study | COMPLETED | Valbenazine (Adults) | 49 | |
| Overall Study | NOT COMPLETED | Valbenazine (Children) | 10 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events69
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 | Nausea | Gastrointestinal disorders | Valbenazine (Children) | 2 | 33 | |
| other | Nausea | Gastrointestinal disorders | Valbenazine (Adolescents) | 1 | 40 | |
| other | Nausea | Gastrointestinal disorders | Valbenazine (Adults) | 3 | 79 | |
| other | Vomiting | Gastrointestinal disorders | Valbenazine (Children) | 3 | 33 | |
| other | Vomiting | Gastrointestinal disorders | Valbenazine (Adolescents) | 2 | 40 | |
| other | Vomiting | Gastrointestinal disorders | Valbenazine (Adults) | 1 | 79 | |
| other | Fatigue | General disorders | Valbenazine (Children) | 5 | 33 | |
| other | Fatigue | General disorders | Valbenazine (Adolescents) | 4 | 40 | |
| other | Fatigue | General disorders | Valbenazine (Adults) | 13 | 79 | |
| other | Irritability | General disorders | Valbenazine (Children) | 4 | 33 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Valbenazine (Children) | 0 | 33 |
| Total, all-cause mortality | Valbenazine (Adolescents) | 0 | 40 |
| Total, all-cause mortality | Valbenazine (Adults) | 0 | 79 |
| Total, other adverse events | Valbenazine (Children) | 19 | 33 |
| Total, other adverse events | Valbenazine (Adolescents) | 22 | 40 |
| Total, other adverse events | Valbenazine (Adults) | 57 | 79 |
| Total, serious adverse events | Valbenazine (Children) | 0 | 33 |
| Total, serious adverse events | Valbenazine (Adolescents) | 0 | 40 |
| Total, serious adverse events | Valbenazine (Adults) | 2 | 79 |
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/NCT02879578
GET https://conductscience.org/api/trials/v1/NCT02879578/events?page=2