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

Tic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241176
• Other study ID #: H12189
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: December 14, 2012
• Start date: September 2005
• Est. completion date: February 2010

Study information

• Verified date: December 2012
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Tic Disorders
• Tics
• Tourette Syndrome
• Tourette's Syndrome

Intervention

Drug:
• Aripiprazole
Baseline Visit 2: Subjects btw 25-50kg start on 1.25mg/day, btw 50-70kg start on 2.5mg/day, greater than 70kg start on 5mg/day Visit 3: Titrated based on YGTSS & CGI-TS ratings at investigator discretion. Subjects who show evidence of response (reduction in CGI-TS by 1-2 points) may remain on same dose. Subjects who show no response may increase as follows: btw 25-50kg increase to 2.5mg/day, btw 50-70kg increase to 3.75mg/day, greater than 70kg increase to 7.5mg/day Visit 5: Subjects who show no response may increase as follows: btw 25-50kg increase to 3.75mg/day, btw 50-70kg increase to 5mg/day, greater than 70kg increase to 10mg/day Visit 6: Subjects who show no response may be increase as follows: btw 25-50kg increase to 5mg/day, btw 50-70kg increase to 7.5mg/day, greater than 70kg increase to 12.5mg/day Visit 7: Subjects who how no response may be increase as follows: btw 25-50kg increase to 7.5mg/day, btw 50-70kg increase to 10mg/day, greater than 70kg increase to 15mg/day

Locations

Country	Name	City	State
United States	NYU Child Study Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)	The Yale Global Tic Severity Scale (YGTSS) is a clinical rating instrument that was designed for use in studies of Tourette's syndrome and other tic disorders. The YGTSS provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The maximum YGTSS Global score is 100, while the maximum motor score is 25, the maximum vocal score is 25, and the maximum impairment score is 50. Higher scores indicate more severe tics.	Baseline, Weekly Visits, Endpoint	No
Secondary	Clinical Global Impression Severity Scores	The Clinical Global Impression scale (CGI) is a classic instrument for making global assessments. This scale yields three different measures: 1. Severity of illness (7-point scale, with 7 being the most impaired; assessment of patient's current symptom severity, referred to here as CGIs), 2. Global improvement (7-point scale, with 7 being the most impaired; comparison of patient's baseline condition with his/her current condition, referred to here as CGIi), 3. Efficacy index (4 point x 4 point rating scale, comparison of patient's baseline condition with a ratio of current therapeutic benefit to severity of side effects)	Baseline and Endpoint (Week 8, Visit 8)	No

External Links

•   NYU Child Study Center website