Open Label Trial of Aripiprazole in Children and Adolescents With Tourette’s Disorder

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Brief Title

Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

Official Title

Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder

Brief Summary

      The purpose of this study is to determine if Abilify will reduce tics (repetitive,
      uncontrollable movements or vocalizations) in children and adolescents ages 7-18 with
      Tourette's Disorder (TD) or a chronic motor tic disorder (either repetitive, uncontrollable
      movements or vocalizations).

Detailed Description

      The aims of this study are to obtain systematic data regarding dosing and safety of
      aripiprazole (Abilify) in the treatment of youth with Tourette's Disorder (TD). Tourette's
      Disorder is characterized by multiple motor (more than one uncontrollable movement) and vocal
      tics (vocal outbursts) which have been present for more than 1 year, with onset before the
      age of 18. The disorder causes marked distress in social, occupational or other important
      areas of functioning. Abilify has been approved by the United States Food and Drug
      Administration (FDA) to treat adults with schizophrenia but has not been approved to treat
      Tourette's Disorder (TD) so it is considered experimental or investigational in this study.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)

Secondary Outcome

 Clinical Global Impression Severity Scores

Condition

Tourette's Syndrome

Intervention

Aripiprazole

Study Arms / Comparison Groups

 Aripiprazole
Description:

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

11

Start Date

September 2005

Completion Date

February 2010

Primary Completion Date

August 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Child or adolescent must be 7 to 18 years of age (inclusive) when informed consent is
             obtained.

          -  Must meet full criteria for Tourette's Disorder or chronic motor tic disorder.

          -  Must have failed to respond to an adequate trial, as determined by the investigator,
             of clonidine, guanfacine, or neuroleptic medication in the past.

          -  Tics are causing significant distress or impairment, as determined by parent/subject
             and principal investigator, on current treatment regimen.

          -  Laboratory results, including serum chemistries, hematology, and urinalysis, must show
             no significant abnormalities (significant is defined as laboratory values requiring
             acute medical intervention).

          -  Must be able to swallow pills.

          -  Must be of normal intelligence in the judgment of the investigator.

          -  Must possess an educational level, degree of understanding and command of the English
             language to enable them to communicate suitably with the investigator and study
             coordinator, and to understand the nature of the study.

          -  Subjects and their legal representatives must be considered reliable.

          -  Written informed consent of parents and subjects (ages 18 and above) and assent of
             subjects ages 7-17 will be obtained.

        Exclusion Criteria:

          -  Organic brain disease, for example, traumatic brain injury residua.

          -  Mental retardation as defined by the DSM-IV-TR.

          -  A history of seizure disorder (other than febrile seizure).

          -  A history of Sydenham's Chorea.

          -  Autism, schizophrenia, other psychotic disorder, or bipolar disorder.

          -  A primary diagnosis of a major mood disorder that requires ongoing psychiatric
             treatment.

          -  A neurological disorder other than a tic disorder.

          -  A major medical illness.

          -  Females who are of child bearing age who are unwilling to use birth control or who are
             pregnant, as determined by serum pregnancy test at baseline assessment, or lactating.

          -  Have a past or current history of substance dependence and/or a current history of
             substance abuse or who fail baseline toxic screen.

          -  Have any clinically significant abnormal laboratory result at baseline screening
             including EKG, or blood tests.

          -  Have a history of ongoing or previously undisclosed child abuse (risk of removal from
             home would not allow for consistent caretaker ratings).

Gender

All

Ages

7 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Barbara J Coffey, M.D, M.S., ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00241176

Organization ID

H12189

Responsible Party

Sponsor

Study Sponsor

NYU Langone Health

Study Sponsor

Barbara J Coffey, M.D, M.S., Principal Investigator, NYU School of Medicine, NYU Child Study Center

Verification Date

October 2016