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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416441
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Tourette's Disorder Drug: aripiprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aripiprazole
Once-weekly tablets
Drug: aripiprazole
Open-label Once-weekly formulation of aripiprazole as a flexible-dose regimen
Other Name: ABILIFY (aripiprazole)

Primary Outcome Measures :
  1. Number and percentage of subjects with adverse events [ Time Frame: week 52 ]
  2. Number and percentage of subjects with clinically significant abnormal laboratory test results, vitals, and ECGs [ Time Frame: week 52 ]
  3. 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 ]
  4. 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 ]
    The change from baseline at each scheduled visit will be calculated as the values at the respective scheduled visit minus the baseline values.

  5. Change from baseline in body weight, waist circumference, and BMI at Weeks 12, 24, and 52 [ Time Frame: Weeks 12, 24, and 52 ]
    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 :
  1. Change from Baseline to endpoint in YGTSS TTS [ Time Frame: week 52 ]
  2. Mean CGI-TS change score at endpoint (change score obtained from CGI-TS improvement scale assessment) [ Time Frame: week 52 ]
  3. Mean change from Baseline to endpoint in Total YGTSS score [ Time Frame: week 52 ]
  4. Response rates [ Time Frame: week 52 ]
  5. Treatment discontinuation rates [ Time Frame: week 52 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416441

  Hide Study 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, 30308
Atlanta, Georgia, United States, 30329
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
Ruse, Bulgaria, 7004
Sofia, Bulgaria, 1431
Varna, Bulgaria, 9010
Calgary, Canada, T3B 6A8
Kelowna, Canada, V1Y 1Z9
Toronto, Canada, M5B 1T9
Toronto, Canada, M5T 2S8
Whitby, Canada, L1N 8M7
Aachen, Germany, 52074
Dresden, Germany, 1307
Hannover, Germany, 30625
Muenchen, Germany, 80336
Ulm, Germany, 89075
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, 138-736
Seoul, Korea, Republic of, 143-729
Culiacán, Mexico, 80020
Del. Miguel Hidalgo, Mexico, 11000
Durango, Mexico, 34000
Leon, Mexico, 37000
Monterey, Mexico, 64710
Bucuresti, Romania, 41915
Cluj-Napoca, Romania, 400660
Craiova, Romania, 200620
Iasi, Romania, 700265
Changhua, Taiwan, 50006
Kaohsiung, Taiwan, 83301
Taichung, Taiwan, 40447
Taipei, Taiwan, 100
Taipei, Taiwan, 114
Donetsk, Ukraine, 83008
Kharkiv, Ukraine, 61068
Kharkiv, Ukraine, 61153
Kyiv, Ukraine, 03049
Kyiv, Ukraine, 4209
Lugansk, Ukraine, 91045
Poltava, Ukraine, 36006
s. Stepanivka Kherson, Ukraine, 73488
Vinnytsia, Ukraine, 21005
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT01416441     History of Changes
Other Study ID Numbers: 31-10-274
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Tourette Syndrome
Pathologic Processes
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
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs