Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder (Anchor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04174365
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent subjects, aged 5 to 17, with irritability associated with autism spectrum disorder.

Condition or disease Intervention/treatment Phase
Irritability Associated With Autism Spectrum Disorder (ASD) Drug: Brexpiprazole Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Trial of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : February 23, 2022
Estimated Study Completion Date : February 23, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole Drug: Brexpiprazole
Oral tablet; take once daily
Other Name: brexpiprazole, OPC-34712 and LuAF41156

Placebo Comparator: Placebo
No Intervention
Drug: Placebo
No Intervention




Primary Outcome Measures :
  1. The mean change from baseline to Week 8 in the Aberrant Behavior Checklist- Irritability subscale score (ABC-I) [ Time Frame: From baseline to Week 8 visit ]

Secondary Outcome Measures :
  1. The mean change from baseline to Week 8 in the Clinical Global Impression- Severity of Illness Scale (CGI-S) score pertaining to irritability [ Time Frame: From baseline to Week 8 visit ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Primary DSM-5 diagnosis of Autism Spectrum Disorder
  • ABC-I subscale score of ≥ 18
  • CGI-S scale score pertaining to irritability ≥ 4
  • Mental age of ≥ 2 years as determined by Investigator based upon school participation, social history or medical records
  • Ability for parent/caregiver to follow all protocol procedures
  • Able to swallow tablets
  • Able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period

Key Exclusion Criteria:

  • Primary diagnosis of bipolar I disorder, including any DSM-5 current diagnosis of bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode, PTSD. ADHD maybe exclusionary if it is the primary disorder, or is not stable or adequately treated.
  • current or historical diagnosis of Fragile-X Syndrome or Rett's Disorder
  • history of neuroleptic malignant syndrome
  • a significant risk of committing violent acts, serious self-harm, or suicide
  • epilepsy, a history of seizures, or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions
  • current hypothyroidism or hyperthyroidism
  • uncontrolled Type I or Type II diabetes
  • uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
  • Weight < 15 kg
  • Previous exposure to brexpiprazole
  • Sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study

Information from the National Library of Medicine

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): NCT04174365


Contacts
Layout table for location contacts
Contact: OPDC Call Center 1-844-687-8522 OtsukaRMReconciliation@rmpdc.org

Locations
Layout table for location information
United States, New Jersey
For additional information regarding sites Recruiting
Princeton, New Jersey, United States, 08540
Contact: contact by phone or email    844-687-8522    OtsukaRMReconciliation@rmpdc.org   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT04174365    
Other Study ID Numbers: 331-201-00148
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: November 2019

Layout table for additional information
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
Irritability
Autism Spectrum Disorder
ASD
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents