Phase 3
N=170
Safety and Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Tourette's Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01416441 ↗Enrolled (actual)
170
Serious AEs
2.9%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation — 5; 8; 6; 104 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
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation |
5; 8; 6; 104 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Laboratory Parameter Values |
0; 1; 1; 4; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values |
1; 0; 1; 0; 4; 3 | — |
| PRIMARY 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) |
3; 3; 4 | — |
| PRIMARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score |
-0.1; -0.1; -0.4; -0.5; -0.5; -0.6 | — |
| PRIMARY Mean Change From Baseline in Body Mass Index (BMI) |
0.6; 0.4; 0.7; 0.6 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs |
1; 0; 4; 0; 0; 1 | — |
| PRIMARY Mean Change From Baseline in Simpson Angus Scale (SAS) Score |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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) |
-0.1; 0; -0.1; -0.1; -0.1; -0.2 | — |
| PRIMARY Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score |
-0.2; -0.2; -0.3; -0.4; -0.4; -0.5 | — |
| PRIMARY Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score |
0; 0; -0.2; -0.4; -0.3; -0.2 | — |
| PRIMARY Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score |
-0.1; -0.2; -0.3; -0.3; -0.3; -0.3 | — |
| PRIMARY Mean Change From Baseline in Body Weight |
1.4; 2.5; 4.7; 3.8 | — |
| PRIMARY Mean Change From Baseline in Waist Circumference |
0.4; 1; 2.3; 1.9 | — |
| SECONDARY Mean Change From Baseline in Yale Global Tic Severity Scale (YGTSS) Total Tic Score |
-2.6; -3.8; -4.5; -4.6; -5.5; -5.8 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression for Tourette's Syndrome (CGI-TS) Severity of Illness Score |
-0.2; -0.4; -0.4; -0.5; -0.6; -0.5 | — |
| SECONDARY Mean Change From Baseline in Total YGTSS Score |
-5.6; -7.4; -8.6; -9.4; -10.7; -10.4 | — |
| SECONDARY Response Rates |
66.2; 69.7; 72.6; 72.3; 74.2; 71.8 | — |
| SECONDARY Treatment Discontinuation Rates |
47.6; 22.4 | — |
| SECONDARY Mean Change From Baseline in Gilles de la Tourette Quality of Life (GTS-QOL) Overall Score |
-2.9; -3.6; -4.3; -3.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01416441). 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.