Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome

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Brief Title

Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome

Official Title

A Phase 1b, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome

Brief Summary

      This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and
      pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome
      (TS). The study will be conducted in approximately 18 male and female children (6 to 11 years
      of age) and approximately 18 male and female adolescents (12 to 18 years of age). Both age
      groups will be divided equally into 3 dosing cohorts with 6 subjects each. Ascending doses
      will be evaluated as part of a staggered-cohort design. Study drug will be administered in
      each cohort for 14 consecutive days.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of participants with adverse events following dosing with NBI-98854

Secondary Outcome

 Assessment of tic behaviors associated with TS using the Rush Video-based Tic Rating Scale (RTRS)

Condition

Tourette Syndrome

Intervention

NBI-98854

Study Arms / Comparison Groups

 Adolescents Dose Group 1
Description:  Fixed dose of NBI-98854 administered once daily at 0800 for 14 days.

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

36

Start Date

September 2014

Completion Date

December 2015

Primary Completion Date

November 2015

Eligibility Criteria

        Inclusion Criteria:

          1. Have documentation of written informed consent, or written and witnessed assent from
             the subject and written informed consent from the subject's parent or legal guardian.

          2. Be in good general health.

          3. Have a Diagnostic and Statistical Manual of Mental Disorders diagnosis of Tourette
             Syndrome (DSM-IV or -V).

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

          5. If medications are being used to treat TS symptoms, must be on stable doses of these
             medications for a minimum of 30 days before baseline (Day -1), and the medication
             regimen is expected to remain stable throughout the study period. The use of
             tetrabenazine to treat TS symptoms is prohibited.

          6. Subjects of childbearing potential who do not practice total abstinence must be
             instructed on the proper use of barrier methods of contraception and agree to use
             hormonal or two forms of nonhormonal contraception consistently from screening until
             30 days after the last dose of study drug.

          7. Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for
             amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or
             cannabinoids. Subjects who are on stable doses of prescribed benzodiazepines, opiates,
             or psychostimulants are allowed to participate in the study.

          8. Adolescent subjects (12 to 18 years of age) must have a negative alcohol breath test.

          9. Be willing and able to adhere to the study regimen and study procedures described in
             the protocol and informed consent/assent forms, including all requirements at the
             study center and return for the follow-up visit.

        Exclusion Criteria:

          1. Have an unstable medical condition or chronic disease.

          2. Had a medically significant illness within 30 days of screening.

          3. Excessive use of tobacco and/or nicotine-containing products.

          4. Have a history of substance (drug) dependence or substance or alcohol abuse.

          5. Are currently pregnant or lactating.

          6. Have a known history of neuroleptic malignant syndrome.

          7. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.

          8. Have a cancer diagnosis within 3 years prior to screening, with the exception of
             localized skin cancer or carcinoma in situ of the cervix.

          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.

         10. Have a significant risk of suicidal or violent behavior.

Gender

All

Ages

6 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Chris O'Brien, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02256475

Organization ID

NBI-98854-1403

Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences

Study Sponsor

Chris O'Brien, MD, Principal Investigator, Neurocrine Biosciences

Verification Date

January 2016