Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

January 29, 2022 updated by: Neurocrine Biosciences

Open-Label Safety and Tolerability Study of Optimized Doses of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome

This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00926
        • Neurocrine Clinical Site
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Neurocrine Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Neurocrine Clinical Site
      • San Diego, California, United States, 92108
        • Neurocrine Clinical Site
      • Santa Ana, California, United States, 92705
        • Neurocrine Clinical Site
      • Santa Clarita, California, United States, 91321
        • Neurocrine Clinical Site
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Neurocrine Clinical Site
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Neurocrine Clinical Site
      • Gulf Breeze, Florida, United States, 32561
        • Neurocrine Clinical Site
      • Hialeah, Florida, United States, 33013
        • Neurocrine Clinical Site
      • Orlando, Florida, United States, 32803
        • Neurocrine Clinical Site
      • Orlando, Florida, United States, 32801
        • Neurocrine Clinical Site
      • Saint Petersburg, Florida, United States, 33701
        • Neurocrine Clinical Site
      • Tampa, Florida, United States, 33614
        • Neurocrine Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Neurocrine Clinical Site
      • Naperville, Illinois, United States, 60563
        • Neurocrine Clinical Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Neurocrine Clinical Site
    • Kansas
      • Leawood, Kansas, United States, 66206
        • Neurocrine Clinical Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Neurocrine Clinical Site
      • Bloomfield Hills, Michigan, United States, 48371
        • Neurocrine Clinical Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Neurocrine Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Neurocrine Clinical Site
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Neurocrine Clinical Site
    • New Jersey
      • Mount Arlington, New Jersey, United States, 07856
        • Neurocrine Clinical Site
      • Voorhees, New Jersey, United States, 08043
        • Neurocrine Clinical Site
    • New York
      • Bronx, New York, United States, 10467
        • Neurocrine Clinical Site
      • New York, New York, United States, 10036
        • Neurocrine Clinical Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Neurocrine Clinical Site
    • Ohio
      • Mason, Ohio, United States, 45040
        • Neurocrine Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Neurocrine Clinical Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Neurocrine Clinical Site
    • Texas
      • Dallas, Texas, United States, 75243
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77030
        • Neurocrine Clinical Site
      • Houston, Texas, United States, 77058
        • Neurocrine Clinical Site
      • San Antonio, Texas, United States, 78249
        • Neurocrine Clinical Site
    • Washington
      • Everett, Washington, United States, 98201
        • Neurocrine Clinical Site
      • Tacoma, Washington, United States, 98405
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Have participated in and completed Study NBI-98854-TS2003
  2. Have a clinical diagnosis of Tourette Syndrome (TS)
  3. 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
  4. Be in good general health
  5. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
  6. 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:

  1. Have an active, clinically significant unstable medical condition within 1 month prior to screening
  2. Have a known history of long QT syndrome or cardiac arrhythmia
  3. Have a known history of neuroleptic malignant syndrome
  4. Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
  5. Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2 (VMAT2) inhibitors
  6. Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
  7. Have a known history of substance (drug) dependence, or substance or alcohol abuse
  8. Have a significant risk of suicidal or violent behavior
  9. Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Valbenazine
Valbenazine administered once daily for up to 24 weeks
Drug: Valbenazine
vesicular monoamine transporter 2 (VMAT2) inhibitor
Other Names:
  • NBI-98854

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Baseline through Week 24
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. All qualifying TEAE are reported regardless of threshold.
Baseline through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 8, 2018

Primary Completion (ACTUAL)

July 12, 2019

Study Completion (ACTUAL)

July 12, 2019

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

February 19, 2018

First Posted (ACTUAL)

February 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

January 29, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-98854-TS2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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