Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Autistic Disorder
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|ClinicalTrials.gov Identifier: NCT03487770|
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2018
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Autistic Disorder||Drug: Aripiprazole Oral Solution Drug: Placebo Oral Solution||Phase 3|
Screening Phase: up to 42 days (consisting of a Screening Visit (V1), a washout period and Interim Screening Visit (V1a) when applicable, and a Baseline Visit (V2). The Screening Phase will serve multiple purposes: to allow for appropriate washout of prohibited medications; to allow for review of screening data; to establish a pre-treatment baseline of key outcome measures.
Treatment Phase: The duration of the treatment is 8 weeks. The purpose of the treatment phase is to evaluate the efficacy, safety, tolerability and steady-state plasma trough concentration of aripiprazole in the treatment of serious behavioral problems in children and adolescents with a diagnosis of Autistic Disorder..
Safety Follow-up Phase: All subjects will be followed up for safety (adverse events) at Day 16 after the last medication via telephone.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Flexible-dosed, Placebo-controlled, Parallel-group Clinical Trial Evaluating the Efficacy and Safety of Aripiprazole Oral Solution in Children and Adolescents With Autistic Disorder|
|Actual Study Start Date :||April 9, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Aripiprazole Oral Solution
1 mg/mL, 2 ~ 15 mg/day (2 ~ 15 mL/day), taken once daily for 8 weeks. Administrate about at the same time each day, either before or after meals;
Drug: Aripiprazole Oral Solution
Aripiprazole 2~15 mg/day (2~15 mL/day)
Placebo Comparator: Placebo Oral Solution
2 ~ 15 mg/day (2 ~ 15 mL/day), taken once daily for 8 weeks. Administrate about at the same time each day, either before or after meals.
Drug: Placebo Oral Solution
Placebo 2~15 mg/day (2~15 mL/day)
Other Name: Placebo
- Changes from Baseline to Week 8 (or endpoint) in the ABC-I score [ Time Frame: Baseline and 8 weeks (or endpoint) ]The objective of the primary analysis is to compare the efficacy of aripiprazole flexible-dosed (2 ~ 15 mg/day) with placebo in reducing serious behavioral problems, specifically irritability, agitation and self-injurious behavior, in children and adolescents with a diagnosis of Autistic Disorder. The efficacy is assessed by assessed by change from baseline to endpoint on the Irritability Subscale of the ABC (ABC-I).
- Clinician-rated CGI-I score at Week 8 (or endpoint) [ Time Frame: Baseline and 8 weeks (or endpoint) ]The efficacy is assessed by the clinician-rated CGI-I score at Week 8
- Change in ABC subscale scores from Baseline to Week 8 (or endpoint) [ Time Frame: Baseline and 8 weeks (or endpoint) ]The efficacy is assessed by changes from Baseline to Week 8 (or endpoint) in Social Withdrawal, Hyperactivity, Stereotypy and Inappropriate Speech Subscale scores of the ABC
- Response Rate at Week 8 (or endpoint) (or endpoint) [ Time Frame: Baseline and 8 weeks (or endpoint) ]The response is defined as a reduction ≥25% in ABC-I score compared to the baseline, and a CGI-I score of much improved or very much improved) at Week 8 (or endpoint).The efficacy is assessed by response rate at Week 8 (or endpoint).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487770
|6th affiliated hospital, Peking University|
|Beijing, Beijing, China, 100191|
|Study Director:||Patyman Juma||Otsuka Beijing Research Institute|