Phase 3 N=110 Treatment

Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

Tourette's Disorder · Tic Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01727713 ↗

Enrolled (actual)

110

Serious AEs

3.6%

Results posted

Oct 2015

Primary outcome: Primary: Percentage of Participants With Adverse Events. — 76.4; 4.5; 3.6 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Aripiprazole (Drug)
Age: Pediatric, Adult · 7+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Adverse Events.	76.4; 4.5; 3.6	—
PRIMARY Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.	3.7; 0.9; 13.0; 4.6; 1.9; 0.9	—
PRIMARY Percentage of Participants With Clinically Significant Abnormal Vital Signs.	0.9; 0.9; 9.3; 6.5; 3.7; 0.9	—
PRIMARY Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).	0.9; 0.9; 1.9; 0.9; 1.9; 0.9	—
PRIMARY Mean Change From Baseline in Body Weight.	1.8; 4.8; 5.8; 6.8; 8.0; 7.2	—
PRIMARY Mean Change From Baseline in Body Mass Index (BMI).	3.3; 1.9; 1.8	—
PRIMARY Mean Change From Baseline in Waist Circumference.	2.2; 3.7; 3.5; 4.5; 5.5; 4.6	—
PRIMARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.	-1.0; -1.3; -1.7; -1.8; -2.0; -2.2	—
PRIMARY Change From Baseline in Simpson-Angus Scale (SAS) Total Score.	0.0; -0.0; -0.0; -0.1; -0.2; -0.2	—
PRIMARY Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.	0.0; 0.0; -0.0; -0.1; -0.1; -0.1	—
PRIMARY Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).	-0.1; -0.0; 0.0; -0.1; -0.0; -0.1	—
PRIMARY 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).	-0.2; -0.2; -0.3; -0.2; -0.2; -0.2	—
PRIMARY Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).	-0.2; -0.1; -0.5; -0.6; -0.5; -0.7	—
PRIMARY Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R).	-0.4; -0.4; -0.3; -0.1; 0.2; 0.4	—
PRIMARY Change From Baseline in Pediatric Anxiety Rating Scale (PARS).	-0.3; -0.3; -0.5; -0.4; -0.2; -0.7	—
SECONDARY Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).	-8.6; -6.6	—
SECONDARY Mean Clinical Global Impressions for Tourette's Syndrome (CGI-TS) Change Score at Endpoint.	2.5; 2.5	—
SECONDARY Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.	-0.9; -0.7	—
SECONDARY Mean Change From Baseline to Endpoint in Total YGTSS Score.	-18.0; -14.0	—
SECONDARY Percentage of Participants With Response (Response Rate).	80.4; 81.9; 82.7; 75.0; 77.2; 75.0	—
SECONDARY Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).	31.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01727713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.