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

Study Description

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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

Study Design

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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

Arms and Interventions

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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)

Outcome Measures

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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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 39 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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