search
Back to results

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

Primary Purpose

Tourette's Syndrome, Tic Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette's Syndrome focused on measuring Psychiatric, Clinical Trial, Pediatrics, Tourette's Disorder, Tic Disorder

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • NYU Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
October 14, 2005
Last Updated
October 26, 2016
Sponsor
NYU Langone Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00241176
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette's Syndrome, Tic Disorders
Keywords
Psychiatric, Clinical Trial, Pediatrics, Tourette's Disorder, Tic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
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
Primary Outcome Measure Information:
Title
Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales)
Description
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.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression Severity Scores
Description
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)
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J Coffey, M.D, M.S.
Organizational Affiliation
NYU School of Medicine, NYU Child Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Child Study Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.aboutourkids.org/
Description
NYU Child Study Center website

Learn more about this trial

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

We'll reach out to this number within 24 hrs