Clinical trial NCT01418352: Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tourette's Disorder
Keywords: Tourette's Disorder
Tic disorders
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-17
Enrollment: 83
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's Disorder.


Eligibility criteria: Inclusion Criteria:

* 7 to 17 year old with diagnostic and statistical manual of mental disorders, fourth edition -text revision (DSM-IV-TR) diagnostic criteria for Tourette's disorder (TD), confirmed by the kiddie schedule for affective disorders and schizophrenia - present and lifetime version (K-SADS-PL), including the Diagnostic Supplement 5
* Has a total tic score (TTS) ≥20 on the yale global tic severity scale (YGTSS) at Screening and Baseline
* Presenting tic symptoms cause impairment in the participant'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 informed consent form (ICF) obtained from a legally acceptable representative \& informed assent at Screening as applicable by study center's Institutional review board/independent ethics committee (IRB/IEC)
* The participant, 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.
* Participant receiving psychostimulants for treatment of attention-deficit disorder/Attention-deficit hyperactivity disorder (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 obsessive-compulsive disorder (OCD), per children's yale-brown obsessive compulsive scale (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 participants not using 2 approved methods of contraception; breastfeeding or pregnant.
* Risk of committing suicide
* Bodyweight lower than 16 kg
* Taken neuroleptic or antiparkinson drugs \<14 days prior to randomization.
* Requiring cognitive-behavioral therapy (CBT) for TD during study.
* Participant meets DSM-IV-TR criteria for any significant psychoactive substance use disorder within the past 3 months.
* Positive drug screen
* Participant 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 study.
* Inability to swallow tablets or tolerate oral medication
* Abnormal laboratory test results, vital signs and Electrocardiogram (ECG) results

Primary outcomes:
measure: Mean Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Mean Change From Baseline in Clinical Global Impressions Scale for Tourette's Syndrome (CGI-TS) Score
timeFrame: Baseline and Week 8
measure: Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score at Week 8
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: San Francisco
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Omaha
country: United States
state: Nebraska
city: Manhasset
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Charlottesville
country: United States
state: Virginia
city: La Crosse
country: United States
state: Wisconsin
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Aachen
country: Germany
city: Dresden
country: Germany
city: Hannover
country: Germany
city: Muenchen
country: Germany
city: Ulm
country: Germany
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lugansk
country: Ukraine
city: Poltava
country: Ukraine
city: Stepanivka
country: Ukraine
city: Vinnytsia
country: Ukraine
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Eva Kohegyi, MD
role: STUDY_DIRECTOR
References: