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

Brief Title

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

Official Title

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

Brief Summary

      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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Frequency of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome

 Severity of tic symptoms assessed by Yale Global Tic Severity Scale (YGTSS)

Condition

Tourette Syndrome

Intervention

NBI-98854

Study Arms / Comparison Groups

 NBI-98854

Description:  NBI-98854 administered once daily for up to 24 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

85

Start Date

February 8, 2018

Completion Date

July 12, 2019

Primary Completion Date

July 12, 2019

Eligibility Criteria

        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 screening

          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
      

Gender

All

Ages

6 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Chief Medical Officer, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

NCT ID

NCT03444038

Organization ID

NBI-98854-TS2004

Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences

Study Sponsor

Chief Medical Officer, Study Director, Chief Medical Officer

Verification Date

February 2020