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NCT02256475 · ClinicalTrials.gov registry record · Phase 1
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
A Phase 1 study, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT02256475: Completed Phase 1 study, sponsored by Neurocrine Biosciences.
NCT02256475 is a Phase 1 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02256475, a Phase 1 study, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses will be evaluated as part of a staggered-cohort design. Study drug will be administered in each cohort for 14 consecutive days.
Interventions
- DRUG NBI-98854
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT02256475 record still lists
NCT02256475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which NBI-98854 is the first listed.
NCT02256475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02256475 about?
NCT02256475 is a clinical study titled "Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome". This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years of age) and approx...
What is the current status of trial NCT02256475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2014-09. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02256475?
The interventions under investigation include: NBI-98854 (DRUG).
Who is sponsoring clinical trial NCT02256475?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02256475's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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