Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
- Conditions
- Irritability Associated With Autism Spectrum DisorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-004899-35-Outside-EU/EEA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study
Autism Spectrum Disorder
Completion of 331-201-00148 trial
Investigator assessment
Are the trial subjects under 18? yes
Number of subjects for this age range: 95
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study
Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose
Female with positive pregnancy test
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method