Trials / Terminated
TerminatedNCT03732534
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette Syndrome
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-98854 | vesicular monoamine transporter 2 (VMAT2) inhibitor |
Timeline
- Start date
- 2018-10-17
- Primary completion
- 2019-02-18
- Completion
- 2019-02-18
- First posted
- 2018-11-06
- Last updated
- 2022-04-19
- Results posted
- 2022-04-19
Locations
10 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03732534. Inclusion in this directory is not an endorsement.