Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome

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Brief Title

Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome

Official Title

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

Brief Summary

      Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of
      NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment. This study will
      enroll approximately 90 male and female pediatric subjects clinically diagnosed with Tourette
      Syndrome.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)

Secondary Outcome

 Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6

Condition

Tourette Syndrome

Intervention

NBI-98854

Study Arms / Comparison Groups

 Placebo
Description:  Administered once daily for 6 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

98

Start Date

March 23, 2016

Completion Date

April 14, 2017

Primary Completion Date

April 14, 2017

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

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02679079

Organization ID

NBI-98854-1501

Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences

Study Sponsor

, ,

Verification Date

December 2020