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Efficacy & Safety 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: NCT01418339
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : November 18, 2014
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The goal of the current trial is to determine efficacy and safety of Once-weekly aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Condition or disease Intervention/treatment Phase
Tourette's Disorder Drug: aripiprazole Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Flexible-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Study Start Date : July 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Matching Placebo
Once weekly matching placebo
Drug: Placebo
Dose of matching placebo tablets for 8 weeks

Experimental: Aripiprazole
Once-weekly tablets
Drug: aripiprazole
Flexible dose of once-weekly aripiprazole tablets
Other Name: ABILIFY (aripiprazole)

Primary Outcome Measures :
  1. Primary efficacy measure is change from Baseline to endpoint (week 8) of the Yale Global Tic Severity Scale (YGTSS). [ Time Frame: baseline and week 8 ]

Secondary Outcome Measures :
  1. The key secondary efficacy endpoints will be the CGI-TS change score at endpoint (week 8) (change score obtained from CGI-TS improvement scale assessment) and the mean changes from Baseline to endpoint (week 8) in GTS-QOL overall score. [ Time Frame: baseline and week 8 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 7 to 17 year old with DSM-IV-TR diagnostic criteria for TD, confirmed by the K-SADS-PL, including the Diagnostic Supplement 5
  • Has a TTS ≥ 20 on the YGTSS at Screening and Baseline
  • Presenting tic symptoms cause impairment in the subject's normal routines, which include academic achievement, occupational functioning, social activities, and/or relationships
  • Females of childbearing potential must have a negative pregnancy test, must be practicing acceptable double-barrier methods of contraception and must not be pregnant or lactating.
  • Written ICF obtained from a legally acceptable representative & informed assent at Screening 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:

  • Clinical presentation and/or history, consistent with another neurologic condition that may have accompanying abnormal movements.
  • History of schizophrenia, bipolar disorder, or other psychotic disorder.
  • Subject receiving psychostimulants for treatment of ADD/ADHD and who have developed and/or had exacerbations of tic disorder after initiation of stimulant treatment.
  • Currently meets DSM-IV-TR criteria for a primary mood disorder.
  • Severe OCD, per CY-BOCS score > 16.
  • Taken aripiprazole within 30 days of the Screening visit.
  • Received any investigational agent in a clinical trial within 30 days prior to Screening or who were randomized into a clinical trial with Once-weekly aripiprazole at any time.
  • History of neuroleptic malignant syndrome.
  • Sexually active patients not using 2 approved methods of contraception; breastfeeding or pregnant.
  • Risk of committing suicide
  • Body weight lower than 16 kg
  • Taken neuroleptic or antiparkinson drugs < 14 days prior to randomization.
  • Requiring CBT for TD during trial.
  • Subject meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
  • Positive drug screen
  • Subject requires medications not allowed per protocol
  • Use of CYP2D6 and CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to dosing and for duration of trial
  • Inability to swallow tablets or tolerate oral medication
  • 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): NCT01418339

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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Study Director: Eva Kohegyi, MD Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT01418339     History of Changes
Other Study ID Numbers: 31-10-272
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Tourette's Disorder
tic disorders
Additional relevant MeSH terms:
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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
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists