Trial · NCT02256475
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
NCT02256475, Phase 1, Completed, Neurocrine Biosciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome. Trials, record NCT02256475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02256475
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
- NCT number
- NCT02256475
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tourette Syndrome
- Interventions
- NBI-98854
- First posted
- 2014-10-03
- Last updated
- 2016-01-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with adverse events following dosing with NBI-98854 | Up to 21 days | |
| Primary | Area Under Curve (AUC) of NBI-98854 and its metabolites following repeated daily doses of NBI-98854 | Day 1: predose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose; Day 14: predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168 hours postdose | |
| Primary | Assessment of tic behaviors associated with TS using the Yale Global Tic Severity Scale (YGTSS) | Days 1, 7, 14, and 21 | |
| Secondary | Assessment of tic behaviors associated with TS using the Rush Video-based Tic Rating Scale (RTRS) | Days 1, 7, 14, and 21 | |
| Secondary | Quantification of the premonitory urge phenomena associated with tics using the Premonitory Urge for Tics Scale (PUTS) | Days 1, 7, 14, and 21 | |
| Secondary | Clinical Global Impression of Tourette Syndrome (CGI-TS) | Days 1, 7, 14, and 21 | |
| Secondary | CogState computerized test to assess cognitive function | Day 1 at predose, 2.5 and 8 hours postdose; Day 14 at 8 hours postdose |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT02256475
GET https://conductscience.org/api/trials/v1/NCT02256475/registered