Clinical Trial Details

Overview

Research Study Summary

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of NBI-98854 in Adult Subjects With Tourette Syndrome

Purpose

Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 8 weeks of treatment. This study will enroll approximately 90 male and female subjects clinically diagnosed with Tourette Syndrome.

To Learn more

CW ID: 211714
Date Last Changed: February 15, 2017

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 to 64 Years
Overall Status
Recruiting
Lead Sponsor
Neurocrine Biosciences
Duration
8 Weeks
Facility Type
Out-Patient

Eligibility

Inclusion Criteria:

  • Have a clinical diagnosis of Tourette Syndrome (TS)
  • Have at least moderate tic severity
  • Have TS symptoms that impair school, occupational, and/or social function
  • If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
  • Be in good general health
  • Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates, and a negative alcohol screen
  • 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

Exclusion Criteria:

  • Have an active, clinically significant unstable medical condition within 1 month prior to screening
  • Have a known history of long QT syndrome or cardiac tachy-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
  • Are currently pregnant or breastfeeding
  • Have a known history of substance dependence, substance (drug) or alcohol abuse
  • Have a significant risk of suicidal or violent behavior
  • Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
  • Have a blood loss ≥550 mL or donated blood within 30 days prior to screening

More Info

Protocol #: NBI-98854-1505

Contact

Alexis Wolfe
University of South Florida- Rothman Center for Pediatric Neuropsychiatry
800 6th Street South
St. Petersburg, FL 33701
Phone: 727-767-8230

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