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

Tourette Syndrome Clinical Trial

Official title:

Open-Label Rollover Study for Continuing NBI-98854 Administration for the Treatment of Pediatric Subjects With Tourette Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03732534
• Other study ID #: NBI-98854-TS2007
• Status: Terminated
• Phase: Phase 2
• Start date: October 17, 2018
• Est. completion date: February 18, 2019

Study information

• Verified date: March 2022
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• NBI-98854
vesicular monoamine transporter 2 (VMAT2) inhibitor

Locations

Country	Name	City	State
Puerto Rico	Neurocrine Clinical Site	San Juan
United States	Neurocrine Clinical Site	Anaheim	California
United States	Neurocrine Clinical Site	Chicago	Illinois
United States	Neurocrine Clinical Site	Dallas	Texas
United States	Neurocrine Clinical Site	Gulf Breeze	Florida
United States	Neurocrine Clinical Site	Hialeah	Florida
United States	Neurocrine Clinical Site	Houston	Texas
United States	Neurocrine Clinical Site	Lincoln	Nebraska
United States	Neurocrine Clinical Site	Naperville	Illinois
United States	Neurocrine Clinical Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 16 Weeks