Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
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ClinicalTrials.gov Identifier: NCT01418339 |
Recruitment Status
:
Completed
First Posted
: August 17, 2011
Last Update Posted
: November 18, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tourette's Disorder | Drug: aripiprazole Drug: Placebo | Phase 3 |
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 |

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
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Drug: aripiprazole
Flexible dose of once-weekly aripiprazole tablets
Other Name: ABILIFY (aripiprazole)
|
- 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 ]
- 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 ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT01418339

Study Director: | Eva Kohegyi, MD | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
ClinicalTrials.gov 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:
Disease 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 Aripiprazole Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |