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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01416441
First received: August 1, 2011
Last updated: March 18, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 170
Study Start Date: August 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416441

  Hide Study Locations
Locations
United States, Alabama
Dothan, Alabama, United States, 36303
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Los Angeles, California, United States, 90095
Sacramento, California, United States, 95815
San Diego, California, United States, 92108
San Francisco, California, United States, 94143
Santa Ana, California, United States, 92701
Wildomar, California, United States, 92595
United States, Florida
Gainesville, Florida, United States, 32610
Hialeah, Florida, United States, 33012
Miami, Florida, United States, 33126
Orange City, Florida, United States, 32763
St. Petersburg, Florida, United States, 33701
United States, Georgia
Atlanta, Georgia, United States, 30329
Atlanta, Georgia, United States, 30308
United States, Illinois
Chicago, Illinois, United States, 60612
United States, Indiana
Indianapolis, Indiana, United States, 46202-5200
United States, Kansas
Overland Park, Kansas, United States, 66211
United States, Louisiana
New Orleans, Louisiana, United States, 70114
United States, Michigan
Bloomfield Hills, Michigan, United States, 48302
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New York
Manhasset, New York, United States, 11030
Staten Island, New York, United States, 10312
United States, Ohio
Avon Lake, Ohio, United States, 44012
Cincinnati, Ohio, United States, 45229-3039
Cleveland, Ohio, United States, 44106
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Dallas, Texas, United States, 75230
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78258
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
Bothell, Washington, United States, 98011
United States, Wisconsin
La Crosse, Wisconsin, United States, 54601
Bulgaria
Ruse, Bulgaria, 7004
Sofia, Bulgaria, 1431
Varna, Bulgaria, 9010
Canada
Calgary, Canada, T3B 6A8
Kelowna, Canada, V1Y 1Z9
Toronto, Canada, M5T 2S8
Toronto, Canada, M5B 1T9
Whitby, Canada, L1N 8M7
Germany
Aachen, Germany, 52074
Dresden, Germany, 1307
Hannover, Germany, 30625
Muenchen, Germany, 80336
Ulm, Germany, 89075
Hungary
Budapest, Hungary, 1021
Szeged, Hungary, 6725
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 420-767
Gyeongnam, Korea, Republic of, 626-770
Incheon, Korea, Republic of, 400-711
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 143-729
Seoul, Korea, Republic of, 138-736
Mexico
Culiacán, Mexico, 80020
Del. Miguel Hidalgo, Mexico, 11000
Durango, Mexico, 34000
Leon, Mexico, 37000
Monterey, Mexico, 64710
Romania
Bucuresti, Romania, 41915
Cluj-Napoca, Romania, 400660
Craiova, Romania, 200620
Iasi, Romania, 700265
Taiwan
Changhua, Taiwan, 50006
Kaohsiung, Taiwan, 83301
Taichung, Taiwan, 40447
Taipei, Taiwan, 100
Taipei, Taiwan, 114
Ukraine
Donetsk, Ukraine, 83008
Kharkiv, Ukraine, 61068
Kharkiv, Ukraine, 61153
Kyiv, Ukraine, 4209
Kyiv, Ukraine, 03049
Lugansk, Ukraine, 91045
Poltava, Ukraine, 36006
s. Stepanivka Kherson, Ukraine, 73488
Vinnytsia, Ukraine, 21005
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: March 18, 2014
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 July 24, 2014