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

Primary Purpose

Tourette Syndrome

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NBI-98854
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Have a clinical diagnosis of Tourette Syndrome (TS)
  2. Have participated in the NBI-98854-TS2004 or NBI 98854-TS2005 Phase 2 studies
  3. 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
  4. Be in good general health
  5. 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 before 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 VMAT2 inhibitors
  6. Have a blood loss ≥250 mL or donated blood within 56 days, or donated plasma within 7 days, before the start of the study
  7. Have a known history of substance dependence, substance (drug) or alcohol abuse within 3 months before the start of the study
  8. Have a significant risk of suicidal or violent behavior
  9. 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
  10. Are currently participating in another NBI-98854 clinical study
  11. Are pregnant (for females)

Sites / Locations

  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site
  • Neurocrine Clinical Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NBI-98854

Arm Description

NBI-98854 administered once daily for up to 96 weeks

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.

Secondary Outcome Measures

Full Information

First Posted
November 5, 2018
Last Updated
March 25, 2022
Sponsor
Neurocrine Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT03732534
Brief Title
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
Official Title
Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Study stopped early due to investigational drug not meeting primary endpoint in the main study T-Force GOLD (NBI-98854-TS2003); no safety concerns identified.
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
February 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocrine Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NBI-98854
Arm Type
Experimental
Arm Description
NBI-98854 administered once daily for up to 96 weeks
Intervention Type
Drug
Intervention Name(s)
NBI-98854
Other Intervention Name(s)
Valbenazine
Intervention Description
vesicular monoamine transporter 2 (VMAT2) inhibitor
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
Up to 16 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Lead
Organizational Affiliation
Neurocrine Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
Neurocrine Clinical Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Neurocrine Clinical Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Neurocrine Clinical Site
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Neurocrine Clinical Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Neurocrine Clinical Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Neurocrine Clinical Site
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Neurocrine Clinical Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Neurocrine Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Neurocrine Clinical Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Neurocrine Clinical Site
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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