Clinical trial NCT01727713: Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Official title: An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of 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: 110
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the current trial is to determine 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 additional 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 is a 52-week extension to the double-blind trial.

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:

* Completed participation in Trial 31-12-293
* Written ICF obtained from a legally acceptable representative \& informed assent at Baseline 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:

* Experienced AEs during the double-blind trial (31-12-293) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
* The subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial
* A positive drug screen
* 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
* Abnormal laboratory test results, vital signs and ECG results

Primary outcomes:
measure: Percentage of Participants With Adverse Events.
timeFrame: Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit
measure: Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.
timeFrame: Baseline to Week 52
measure: Percentage of Participants With Clinically Significant Abnormal Vital Signs.
timeFrame: Baseline to Week 52
measure: Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).
timeFrame: Baseline to Week 52
measure: Mean Change From Baseline in Body Weight.
timeFrame: Baseline to Weeks 12, 28, 36, 44, 52/Last visit.
measure: Mean Change From Baseline in Body Mass Index (BMI).
timeFrame: Baseline to Weeks 28, 52 and Last visit.
measure: Mean Change From Baseline in Waist Circumference.
timeFrame: Baseline to Weeks 12, 28, 36, 44, and 52/last visit.
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Simpson-Angus Scale (SAS) Total Score.
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).
timeFrame: Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R).
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
measure: Change From Baseline in Pediatric Anxiety Rating Scale (PARS).
timeFrame: Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit
Secondary outcomes:
measure: Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
timeFrame: Baseline to Week 52
measure: Mean Clinical Global Impressions for Tourette's Syndrome (CGI-TS) Change Score at Endpoint.
timeFrame: Baseline to Week 52
measure: Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.
timeFrame: Baseline to Week 52
measure: Mean Change From Baseline to Endpoint in Total YGTSS Score.
timeFrame: Baseline to Week 52
measure: Percentage of Participants With Response (Response Rate).
timeFrame: Weeks 4, 8, 12, 20, 28, 36, 44 and 52
measure: Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Goodyear
country: United States
state: Arizona
city: Orange City
country: United States
state: California
city: Sacramento
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: Orange City
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
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: Manhasset
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Avon Lake
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
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: Norfolk
country: United States
state: Virginia
city: Petersburg
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Toronto
country: Canada
state: Ontario
city: Whitby
country: Canada
state: Ontario
city: Nova Scotia
country: Canada
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Catania
country: Italy
city: Milano
country: Italy
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Eva Kohegyi, MD
role: STUDY_DIRECTOR
References: