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

NCT00241176 | Completed Phase 4 Results DMC

• 1 other identifier: H12189
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Tourette's Syndrome; Tic Disorders

Keywords

Psychiatric; Clinical Trial; Pediatrics; Tourette's Disorder; Tic Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  8 Weeks

Secondary Outcomes (1)

• Clinical Global Impression Severity Scores

  24 Months

Study Arms (1)

Aripiprazole

EXPERIMENTAL

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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

Aripiprazole

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Child Study Center

New York, New York, 10016, United States

Location

Related Links

• NYU Child Study Center website

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

All subjects failed to respond to previous tic medications so could have unique tic symptoms, small sample size, and this was an open-label study, so we did not have a comparison group nor were we blinded to treatment.

Results Point of Contact

• Title: Barbara J Coffey, M.D, M.S.
• Organization: NYU School of Medicine, NYU Child Study Center

barbara.coffey@mssm.edu

(212)263-3926

Study Officials

• Barbara J Coffey, M.D, M.S.

  NYU School of Medicine, NYU Child Study Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: February 1, 2010
• Last Updated: December 9, 2016
• Results First Posted: January 25, 2013

Record last verified: 2016-10

Locations

US (1)