Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette's Disorder
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Korea Otsuka Pharmaceutical Co.,Ltd..
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Korea Otsuka Pharmaceutical Co.,Ltd.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00706589
First received: June 25, 2008
Last updated: October 22, 2008
Last verified: October 2008
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Purpose
The purpose of this trial is to demonstrate the efficacy and safety of aripiprazole in children and adolescents aged 6~18 years with chronic tic disorders or Tourette's disorder
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Motor Tic Disorder Chronic Phonic Tic Disorder Tourette's Disorder |
Drug: aripiprazole Drug: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Dose-Adjustment, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole in Children and Adolescents With Chronic Tic Disorders or Tourette's Disorder |
Resource links provided by NLM:
Genetics Home Reference related topics:
Tourette syndrome
MedlinePlus related topics:
Tourette Syndrome
Drug Information available for:
Aripiprazole
U.S. FDA Resources
Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Primary Outcome Measures:
- Mean change in total tic scores on the K-YGTSS [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- (1)Percent change of total tic scores on the K-YGTSS. (2)Response rate assessed with the TS-CGI-Improvement scale. (3)Mean change in scores on the TS-CGI-Severity scale. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 56 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Aripiprazole
|
Drug: aripiprazole
Initial dose : 2mg, Maximum dose : 20mg
Other Name: Abilify
|
|
Placebo Comparator: 2
Placebo
|
Drug: placebo
2mg~20mg
|
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients who can provide an assent form signed by themselves and informed consent form by their legal representatives prior to performing of any study procedures.
- Male or female children and adolescents aged 6 to 18 years
- Patients who are diagnosed with chronic tic disorders(Motor or Phonic) or Tourette's disorder according to DSM-IV (using K-SADS-PL-K) and require drug therapy.
- The total tic score of the K-YGTSS is more than 22 at baseline
Exclusion Criteria:
- Patients with secondary tic symptoms accompanied by Tardive tics, Huntington disease, neuroacanthocytosis, mental retardation, or autism
- Patients with IQ (assessed using KEDI-WISC) 70 and lower than 70
- Patients with a history of neuroleptic malignant syndrome
- Patients with antipsychotic or alcohol use disorder (abuse, dependence, and/or withdrawal) according to DSM-IV criteria for the past 3 months
- Patients with a history of allergy or hypersensitivity reaction to aripiprazole
- Patients with a history of resistance to treatment with antipsychotics
- Patients who have participated in another clinical study within 1 month prior to screening
- Patients who have previously taken aripiprazole or participated in a clinical study with aripiprazole
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706589
Contacts
| Contact: Pum-Soo Kim, MD. Ph.D | 82-2-3472-9811 | pumsoo.kim@otsuka.co.kr |
| Contact: MiRan Moon | 82-2-3472-1311 | mrmoon@otsuka.co.kr |
Locations
| Korea, Republic of | |
| Inha University Hospital | Not yet recruiting |
| Inchon, Korea, Republic of, 400-711 | |
| Contact: JeongSeop Lee, MD. Ph.D 82-32-890-3474 soulfree@inha.ac.kr | |
| Chung-Ang Univ. Medical center | Not yet recruiting |
| Seoul, Korea, Republic of, 156-755 | |
| Contact: YoungSik Lee, MD. Ph.D 82-2-6299-1518 hawkeyelys@hanmail.net | |
| Yonsei University Severance Hospital | Not yet recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: DongHo Song, MD. Ph.D 82-2-2228-1620 dhsong@yuhs.ac | |
| Asan Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Hanik Yoo, MD. Ph.D 82-2-3010-3423 hiyoo@amc.seoul.kr | |
| Samsung Medical Center | Not yet recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: YooSook Joung, MD. Ph.D 82-2-3410-3589 yschoung@skku.edu | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| Contact: SooChurl Cho, MD. Ph.D 82-2-2072-2450 soochurl@snu.ac.kr | |
| Contact: Boong-Nyun Kim, MD. Ph.D 82-2-2072-3647 kbn1@snu.ac.kr | |
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Otsuka Pharmaceutical Co., Ltd.
Investigators
| Principal Investigator: | Soochurl Cho, MD. Ph.D | Seoul National University Hospital |
More Information
No publications provided
| Responsible Party: | MiRan Moon/Clinical Resarch Manager, Korea Otsuka Pharmaceutical Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00706589 History of Changes |
| Other Study ID Numbers: | 031-KOA-0703 |
| Study First Received: | June 25, 2008 |
| Last Updated: | October 22, 2008 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
|
Chronic Motor Tic disorder Chronic Phonic Tic disorder Tourette's disorder Aripiprazole |
Abilify Children Adolescent |
Additional relevant MeSH terms:
|
Tic Disorders Tics Tourette Syndrome Movement Disorders Central Nervous System Diseases Nervous System Diseases Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Signs and Symptoms Basal Ganglia Diseases Brain Diseases |
Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013