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Atypical Antipsychotic
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
Phase 3
Waitlist Available
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to evaluate the safety and tolerability of brexpiprazole in children and adolescents aged 5 to 17 who have irritability associated with autism. The medication helps balance brain chemicals to reduce irritability and improve mood.
Eligible Conditions
- Autism Spectrum Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (in current study) up to 21 days post last dose of study drug (up to approximately 29 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in AIMS Total Score at Week 14
Change From Baseline in AIMS Total Score at Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Week 2
+15 moreSecondary study objectives
Mean Change From Baseline to Week 26 in Aberrant Behavior Checklist - Irritability (ABC-I) Subscale Score
Mean Change From Baseline to Week 26 in Clinical Global Impression - Severity (CGI-S) Scale Score
Side effects data
From 2019 Phase 4 trial • 51 Patients • NCT0314999116%
Dizziness
16%
Alteration in Taste
12%
Restlessness/Akathisia
8%
Headache
8%
Dissociation/Detachment
8%
Insomnia/Sleep disturbance
8%
Sedation
8%
Constipation
8%
Gastric Distress
4%
Elevated alt
4%
Hot flashes
4%
Unsteadiness of gait
4%
Lethargy
4%
Increased appetite
4%
Twitching of left side lower lip
4%
Light headedness
4%
Panic episode
4%
Shakiness
4%
Irritability
4%
Increased salivation post dose
4%
Weight gain
4%
Bruxism
4%
Nausea
4%
Bi-lateral hand pain
4%
Euphoria
4%
Irregular/Early Menses
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brexpiprazole
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BrexpiprazoleExperimental Treatment1 Intervention
Participants received brexpiprazole based on the body weight for 26 weeks in this study.
Participants with body weight \< 50 kilograms (kg), received brexpiprazole tablets orally, once daily (QD) at dose of 0.25 mg on Days 1 to 3 followed by 0.5 mg on Days 4 to 7 and 1 mg on Days 8 to 14. Based on the investigator's judgment, the dose was increased to 1 or 1.5 mg starting from Day 15 until week 26.
Participants with body weight ≥ 50 kg received brexpiprazole tablet orally, QD at dose of 0.5 mg on Days 1 to 3, followed by 1.5 mg on Days 4 to 7, and 2 mg on Days 8 to 14. Based on the investigator's judgment the dose was increased to 1.5, 2, or 3 mg starting from Day 15 until week 26.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexpiprazole
FDA approved
Find a Location
Who is running the clinical trial?
Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
169,003 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
119 Patients Enrolled for Autism Spectrum Disorder
H. Lundbeck A/SIndustry Sponsor
331 Previous Clinical Trials
78,112 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
119 Patients Enrolled for Autism Spectrum Disorder