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

• ClinicalTrials.gov Identifier: NCT00241176
• Recruitment Status: Completed
• First Posted: October 18, 2005
• Results First Posted: January 25, 2013
• Last Update Posted: December 9, 2016
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: October 14, 2005
• First Posted Date: October 18, 2005
• Results First Submitted Date: June 7, 2012
• Results First Posted Date: January 25, 2013
• Last Update Posted Date: December 9, 2016
• Study Start Date: September 2005
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2016)

Calculating Difference Between Means (Baseline and Endpoint Scores on the Yale Global Tic Severity Scale Subscales) [ Time Frame: 8 Weeks ]

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.

• Original Primary Outcome Measures (submitted: October 14, 2005): We will obtain preliminary data on effect size for tics using Cohen's d, calculating the difference between the two means (baseline and endpoint scores on the YGTSS), divided by the standard deviation of the difference

Current Secondary Outcome Measures (submitted: June 15, 2016)

Clinical Global Impression Severity Scores [ Time Frame: 24 Months ]

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)

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Tourette's Syndrome
• Tic Disorders

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

Study Arms

Experimental: Aripiprazole

Intervention: Drug: Aripiprazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2012): 11
• Original Enrollment (submitted: October 14, 2005): 12
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 7 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00241176
• Other Study ID Numbers: H12189
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: NYU Langone Health
• Study Sponsor: NYU Langone Health
• Collaborators: Not Provided

Investigators

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

• PRS Account: NYU Langone Health
• Verification Date: October 2016