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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 is a Phase 1 study that has completed, run by Neurocrine Biosciences. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02256475
The ClinicalTrials.gov registry entry for NCT02256475 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NBI-98854 is the first listed.
NCT02256475 reports 0 study locations.
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.
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