EUCTR2018-004899-35-Outside-EU/EEA
Active, not recruiting
Phase 1
A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
ConditionsIrritability Associated With Autism Spectrum DisorderTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
DrugsRexulti
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Irritability Associated With Autism Spectrum Disorder
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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