Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome

Stopped early · Phase 2

Conditions studied: Tourette Syndrome

In brief

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.

Key facts

Study ID

NCT03732534

Run by

Neurocrine Biosciences

People needed

6

Starts

2018-10-17

Expected to finish

2019-02-18

Last updated by the study team

2022-04-19

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a clinical diagnosis of Tourette Syndrome (TS)
• Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies
• If using maintenance medication(s) for TS and/or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
• Be in good general health
• Subjects of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study

You may not qualify if…

• Have an active, clinically significant unstable medical condition within 1 month before screening
• Have a known history of long QT syndrome or cardiac arrhythmia
• Have a known history of neuroleptic malignant syndrome
• Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
• Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors
• Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7 days, before the start of the study
• Have a known history of substance dependence, substance (drug) or alcohol abuse within 3 months before the start of the study
• Have a significant risk of suicidal or violent behavior
• Have received an investigational drug within 30 days before the start of the study or plan to use an investigational drug (other than NBI-98854) during the study
• Are currently participating in another NBI-98854 clinical study
• Are pregnant (for females)

Where it is running

• Neurocrine Clinical Site — Anaheim, California, United States
• Neurocrine Clinical Site — San Diego, California, United States
• Neurocrine Clinical Site — Gulf Breeze, Florida, United States
• Neurocrine Clinical Site — Hialeah, Florida, United States
• Neurocrine Clinical Site — Chicago, Illinois, United States
• Neurocrine Clinical Site — Naperville, Illinois, United States
• Neurocrine Clinical Site — Lincoln, Nebraska, United States
• Neurocrine Clinical Site — Dallas, Texas, United States
• Neurocrine Clinical Site — Houston, Texas, United States
• Neurocrine Clinical Site — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

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