Clinical trial NCT01727700: Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Fixed-Dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tourette's Disorder
Tic Disorder
Keywords: Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Tic Disorders
Tics
Movement Disorders
Mental Disorders
Aripiprazole
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 133
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-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

Detailed description: Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of medications approved for the treatment of Tourette's Disorder. The goal of the current trial is to obtain efficacy, safety, and tolerability data in a controlled condition of a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder. The trial has an 8-week long double-blind treatment period after a pretreatment (screening/washout phase), and the subjects will be followed up for 1 month after the last treatment. The Once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Eligibility criteria: Inclusion Criteria:

* male or female, 7 to 17 year old (inclusive) at the time of signing consent
* meets DSM-IV-TR diagnostic criteria for Tourette's Disorder
* 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 informed consent 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 Obsessive Compulsive Disorder (OCD)
* Taken aripiprazole within 30 days of the Screening visit
* Received any investigational agent in a clinical trial within 30 days prior to Screening, enrolled in studies 31-12-272, 31-12-273, 31-12-274; or who were randomized into a clinical trial with Once-daily aripiprazole at any time
* History of neuroleptic malignant syndrome
* Sexually active patients not using 2 approved methods of contraception
* Females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug)
* Risk of committing suicide
* Body weight lower than 16 kg
* Taken neuroleptic or antiparkinson drugs \< 14 days prior to randomization
* Requiring cognitive behavioral therapy (CBT) for Tourette's 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
* Use of herbal medications of any kind and nutritional or dietary supplements for Tourette's disorder within 7 days prior to dosing and for the duration of the trial
* Inability to swallow tablets or tolerate oral medication
* Abnormal laboratory test results, vital signs and ECG results

Primary outcomes:
measure: Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.
timeFrame: Week 8
measure: Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score
timeFrame: Baseline to Week 8
measure: Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score
timeFrame: Baseline to Week 8
measure: Response Rate
timeFrame: Week 8
measure: Treatment Discontinuation Rate
timeFrame: Week 8
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Goodyear
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Corona
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Gainsville
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Naperville
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Waldorf
country: United States
state: Maryland
city: Bloomfield Hills
country: United States
state: Michigan
city: Mt Arlington
country: United States
state: New Jersey
city: Summit
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Mt. Pleasant
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Henrico
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Bothell
country: United States
state: Washington
city: Middleton
country: United States
state: Wisconsin
city: Kentville
country: Canada
state: Nova Scotia
city: Parry Sound
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Whitby
country: Canada
state: Ontario
city: Dresden
country: Germany
city: Freiburg
country: Germany
city: Mannheim
country: Germany
city: Wurzburg
country: Germany
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Catania
country: Italy
city: Milano
country: Italy
city: Roma
country: Italy
city: Durango
country: Mexico
city: Leon
country: Mexico
city: Mexico City
country: Mexico
city: Bucharest
country: Romania
city: Iasi
country: Romania
city: Madrid
country: Spain
city: Goteborg
country: Sweden
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Eva Kohegyi, MD
role: STUDY_DIRECTOR
References:
citation: Sallee F, Kohegyi E, Zhao J, McQuade R, Cox K, Sanchez R, van Beek A, Nyilas M, Carson W, Kurlan R. Randomized, Double-Blind, Placebo-Controlled Trial Demonstrates the Efficacy and Safety of Oral Aripiprazole for the Treatment of Tourette's Disorder in Children and Adolescents. J Child Adolesc Psychopharmacol. 2017 Nov;27(9):771-781. doi: 10.1089/cap.2016.0026. Epub 2017 Jul 7.