Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

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Brief Title

Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

Official Title

A Phase 2, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome

Brief Summary

      This is a Phase 2, double-blind, placebo-controlled, randomized withdrawal study to evaluate
      the safety and maintenance of efficacy of an optimized once-daily (qd) dose of NBI-98854 in
      pediatric subjects with TS.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Overall improvement of Tourette Syndrome with Clinical Global Impression-Tourette Syndrome (CGI-TS-Improvement)

Condition

Tourette Syndrome

Intervention

Valbenazine

Study Arms / Comparison Groups

 Valbenazine
Description:  Capsule, administered once daily. Randomization into this arm occurs after open-label treatment with valbenazine once daily for up to 12 weeks. Total treatment up to 36 weeks.

Publications

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

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

81

Start Date

April 16, 2018

Completion Date

July 12, 2019

Primary Completion Date

July 12, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Have a clinical diagnosis of Tourette Syndrome (TS)

          2. Have at least moderate tic severity

          3. Have TS symptoms that impair school, occupational, and/or social function

          4. 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

          5. Be in good general health

          6. Adolescent subjects (12 to 17 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids and a negative alcohol screen

          7. 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 VMAT2 inhibitors

          6. Have a blood loss ≥250 mL or donated blood within 30 days prior to screening

          7. Have a known history of substance dependence, substance (drug) or alcohol abuse

          8. Have a significant risk of suicidal or violent behavior

          9. Have initiated Comprehensive Behavioral Intervention for Tics (CBIT) during the
             screening period or at baseline or plan to initiate CBIT during the study

         10. Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study

         11. Have previously participated in an NBI-98854 clinical study, except for NBI-98854-1403
             or NBI-98854-1501.

         12. Have HIV, hepatitis B, or hepatitis C

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Chief Medical Officer, ,

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations

NCT ID

NCT03530293

Organization ID

NBI-98854-TS2005

Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences

Study Sponsor

Chief Medical Officer, Study Director, Chief Medical Officer

Verification Date

February 2020