Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04258839
• Collaborator: H. Lundbeck A/S (Industry)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 31.1
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent patients, aged 5 to 17, with irritability associated with autism spectrum disorder.

Condition or Disease	Intervention/Treatment	Phase
Irritability Associated With Autism Spectrum Disorder	Drug: Brexpiprazole	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jan 17, 2020
• Anticipated Primary Completion Date: Aug 20, 2022
• Anticipated Study Completion Date: Aug 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Brexpiprazole	Drug: Brexpiprazole; Oral tablet; taken once daily; Other Names: OPC-34712 LuAF41156

Outcome Measures

Primary Outcome Measures

1. Adverse Events [Baseline to Week 26]

   Adverse Events occurring from baseline to Week 26

Secondary Outcome Measures

1. Aberrant Behavior Checklist (ABC-I) [Baseline to Week 26]

   Aberrant Behavior Checklist- Irritability subscale score (ABC-I)

2. Clinical Global Impression (CGI-S) [Baseline to Week 26]

   Clinical Global Impression - Severity (CGI-S)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding sites	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.
• H. Lundbeck A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT04258839
• Other Study ID Numbers: 331-201-00191
• First Posted: Feb 6, 2020
• Last Update Posted: May 28, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: Autism; Autism Spectrum Disorder; ASD; Irritability
• Additional relevant MeSH terms: Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Brexpiprazole

Study Results

No Results Posted as of May 28, 2020