Clinical trial NCT01416441: Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Official title: An Open-Label, Multicenter Study Evaluating the Safety and Tolerability of 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: 2011-08-15
Enrollment: 170
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 obtain long term efficacy, safety and tolerability data of once weekly aripiprazole in children and adolescents with Tourette's Disorder.


Eligibility criteria: Inclusion Criteria:

* The participants successfully completed the final assessment visit in either Study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352). The participants completed all required assessments for the Week 8/Early Termination Visit to be eligible for rollover in to this open-label trial.
* Written informed consent form (ICF) obtained from a legally acceptable representative \& informed assent at Baseline as applicable by trial 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:

* The participants experienced adverse events (AEs) during the double-blind study 31-10-272 (NCT01418339) or 31-10-273 (NCT01418352) that would, in the investigator's judgment, preclude further exposure to aripiprazole.
* The participants had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the participant a poor candidate for the trial.
* A positive drug screen at baseline for cocaine, alcohol or other drugs of abuse which will result in early termination at Week 1.
* Sexually active patients who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 90 and 30 days following the last dose of study drug for male and female respectively.
* Participants representing Risk of committing suicide.
* Body weight lower than 16 kg.
* Abnormal laboratory test results (Platelet, Hemoglobin, Neutrophils, Aspartate aminotransferase, Alanine aminotransferase, Creatinine) vital signs and Electrocardiogram (ECG) results.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation
timeFrame: From signing of the informed consent up to 30 days after the last dose (Up to Week 52)
measure: Number of Participants With Clinically Significant Changes in Laboratory Parameter Values
timeFrame: Baseline to Week 52
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
timeFrame: Baseline to Week 52
measure: Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline to Week 52
measure: Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline to Week 52
measure: Mean Change From Baseline in Simpson Angus Scale (SAS) Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Body Weight
timeFrame: Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Waist Circumference
timeFrame: Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
Secondary outcomes:
measure: Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Mean Change From Baseline in Total YGTSS Score
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Response Rates
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)
measure: Treatment Discontinuation Rates
timeFrame: Up to Week 53
measure: Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score
timeFrame: Baseline and Weeks 4, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Wildomar
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Saint Petersburg
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: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Bloomfield Hills
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Manhasset
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Avon Lake
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Bothell
country: United States
state: Washington
city: La Crosse
country: United States
state: Wisconsin
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Calgary
country: Canada
city: Kelowna
country: Canada
city: Toronto
country: Canada
city: Toronto
country: Canada
city: Whitby
country: Canada
city: Aachen
country: Germany
city: Dresden
country: Germany
city: Hannover
country: Germany
city: Muenchen
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Szeged
country: Hungary
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeongsang
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Culiacán
country: Mexico
city: Delegación Miguel Hidalgo
country: Mexico
city: Durango
country: Mexico
city: Leon
country: Mexico
city: Monterrey
country: Mexico
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
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: