- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00241176
Open Label Trial of Aripiprazole in Children and Adolescents With Tourette's Disorder
October 26, 2016 updated by: NYU Langone Health
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
11
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Child Study Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Barbara J Coffey, M.D, M.S., NYU School of Medicine, NYU Child Study Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (Estimate)
October 18, 2005
Study Record Updates
Last Update Posted (Estimate)
December 9, 2016
Last Update Submitted That Met QC Criteria
October 26, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Dyskinesias
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Disease
- Tourette Syndrome
- Tic Disorders
- Tics
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- H12189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tic Disorders
-
Istituto Ortopedico GaleazziUnknown
-
University of MinnesotaRecruiting
-
Sohag UniversityNot yet recruitingTic Disorder, ChildhoodEgypt
-
Aarhus University HospitalActive, not recruitingChronic Tic DisorderDenmark
-
University of CologneUnknown
-
Florida International UniversityCompletedComorbidities and Coexisting Conditions | Tic Disorder, ChildhoodUnited States
-
University of CologneUnknown
-
University of CologneUnknown
-
University of MiamiRecruiting
-
Xijing HospitalUnknown
Clinical Trials on Aripiprazole
-
National Institute on Alcohol Abuse and Alcoholism...Brown UniversityCompleted
-
Otsuka Beijing Research InstituteCompleted
-
H. Lundbeck A/SOtsuka Pharmaceutical Co., Ltd.CompletedSchizophreniaUnited States
-
University of California, Los AngelesAlkermes, Inc.TerminatedSchizophrenia | Schizophreniform Disorder | Schizoaffective Disorder, Depressive TypeUnited States
-
Otsuka Pharmaceutical Co., Ltd.CompletedMajor Depressive DisorderJapan
-
Veterans Medical Research FoundationBristol-Myers SquibbCompleted
-
Otsuka Pharmaceutical Development & Commercialization...CompletedSchizophreniaKorea, Republic of, United States, Estonia, Italy, Hungary, Bulgaria, Croatia, France, Poland, Thailand, Puerto Rico, Chile, South Africa, Austria, Belgium
-
Otsuka Pharmaceutical Co., Ltd.CompletedSchizophreniaJapan
-
Alkermes, Inc.CompletedSchizophreniaUnited States
-
Alkermes, Inc.CompletedSchizophreniaUnited States