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Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

This study is currently recruiting participants.
Verified February 2013 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01416441
First received: August 1, 2011
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

The goal of the current trial is to obtain long term efficacy, safety and tolerability data of Once weekly aripiprazole in children and adolescents with Tourette's Disorder.


Condition Intervention Phase
Tourette's Disorder
 Drug: aripiprazole
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Number and percentage of subjects with adverse events [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with suicidality, suicidal behavior and suicidal ideation from the potential suicide events recorded on the C-SSRS [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in EPS scales, ADD/ADHD Subscale of SNAP-IV, CY-BOCS, CDRS-R, and PARS at Weeks 4, 8, 12, 16, 20, 24, 36, 44, and 52 [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, 44, and 52 ] [ Designated as safety issue: No ]
    The change from baseline at each scheduled visit will be calculated as the values at the respective scheduled visit minus the baseline values.

  • Change from baseline in body weight, waist circumference, and BMI at Weeks 12, 24, and 52 [ Time Frame: Weeks 12, 24, and 52 ] [ Designated as safety issue: No ]
    The change from baseline at each scheduled visit will be calculated as the values at the respective scheduled visit minus the baseline values.


Secondary Outcome Measures:
  • Change from Baseline to endpoint in YGTSS TTS [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Mean CGI-TS change score at endpoint (change score obtained from CGI-TS improvement scale assessment) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Mean change from Baseline to endpoint in Total YGTSS score [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Response rates [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Treatment discontinuation rates [ Time Frame: week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aripiprazole
Once-weekly tablets
 Drug: aripiprazole
Open-label Once-weekly formulation of aripiprazole as a flexible-dose regimen
Other Name: ABILIFY (aripiprazole)

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed participation or discontinued due to lack of efficacy at week 5 or later in either Trial 31-10-272 or 31-10-273
  • Written ICF obtained from a legally acceptable representative & informed assent at Baseline as applicable by trial center's IRB/IEC
  • The subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator.

Exclusion Criteria:

  • The subject experienced AEs during the double-blind trial (31-10-272 or 31-10-273) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
  • The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial
  • A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1
  • Sexually active patients not using 2 approved methods of contraception; breastfeeding or pregnant.
  • Risk of committing suicide
  • Body weight lower than 16 kg
  • Abnormal laboratory test results, vital signs and ECG results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416441

Contacts
Contact: CenterWatch tourettes@centerwatch.com

Locations
United States, Michigan
Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States, 19139
United States, Virginia
Not yet recruiting
Norfolk, Virginia, United States, 23510
Canada
Not yet recruiting
Calgary, Canada, T3B 6A8
Not yet recruiting
Toronto, Canada, M5T 2S8
Korea, Republic of
Recruiting
Gyeongsangnam-do, Korea, Republic of, 626-770
Recruiting
Incheon, Korea, Republic of, 400-711
Recruiting
Seoul, Korea, Republic of, 143-729
Recruiting
Seoul, Korea, Republic of, 138-736
Recruiting
Seoul, Korea, Republic of, 110-769
Taiwan
Recruiting
Changhua, Taiwan, 500
Recruiting
Taichung, Taiwan, 40447
Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01416441     History of Changes
Other Study ID Numbers: 31-10-274
Study First Received: August 1, 2011
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Romania: National Medicines Agency
South Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health
Taiwan: Center for Drug Evaluation
Ukraine: State Pharmacological Center - Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Tourette's Disorder
tic disorders

Additional relevant MeSH terms:
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
 Mental Disorders
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 22, 2013