A Study of JZP541 in Adults with Irritability Associated with Autism Spectrum Disorder
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of JZP541 in Adults with Irritability Associated with Autism Spectrum Disorder
IRAS ID
1008073
Contact name
Clinical Trial Disclosure & Transp Clinical Trial Disclosure & Transp
Contact email
Sponsor organisation
Jazz Pharmaceuticals PLC
Clinicaltrials.gov Identifier
Research summary
The primary objective of the study is to compare the efficacy of JZP541 relative to placebo in reducing irritability in adults with Autism Spectrum Disorder (ASD), assessed using the Aberrant Behavior Checklist - Irritability subscale (ABC-I). The ABC-I subscale will be the primary endpoint. The ABC is a well-validated caregiver (study partner)-completed questionnaire with good reliability, designed to measure treatment effects on inappropriate and maladaptive behavior in people with developmental disabilities.
During the study, participants will be randomly assigned to receive twice daily oral suspensions of JZP541 or placebo in a 1:1 ratio.
JZP541 oral suspension is a well characterised botanical mixture derived from the cannabis plant. It contains various cannabinoids and non-cannabinoids including a small amount of the component that causes a 'high' (known as tetrahydrocannabinol or THC).The total duration of the study for each participant will be approximately 4 months, including a screening visit, a 12-week study intervention period, a 4-week follow-up period and an early discontinuation visit (if required).
This study is sponsored by Jazz Pharmaceuticals Inc, on behalf of GW Research Ltd. Approximately 90 people in Europe and America with irritability associated with ASD, aged 18-45, will be invited to take part in this study. Every participant is required to have a study partner who will provide information on the participant during the study.
REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0692
Date of REC Opinion
12 Dec 2023
REC opinion
Further Information Unfavourable Opinion