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JZP541 for Autism

Phase 2
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up until end of study or discontinuation (whichever occurs first), up to approximately 2 years
Awards & highlights

Summary

This trial will study if a drug, JZP541, can help adults with autism spectrum disorder who have irritability, a major safety concern.

Who is the study for?
Adults aged 18-45 with Autism Spectrum Disorder (ASD) experiencing irritability, who have a stable treatment regimen and can self-report side effects. They need an informed study partner and must not be pregnant or planning pregnancy. Excluded are those with recent seizures, psychosis, significant heart disease, suicidal behavior within the last month, severe intellectual disability, or substance abuse.Check my eligibility
What is being tested?
The trial is testing JZP541's effectiveness in reducing irritability in adults with ASD compared to a placebo. Participants will receive either the actual drug or a placebo without knowing which one they're getting to measure true effects of JZP541.See study design
What are the potential side effects?
While specific side effects for JZP541 aren't listed here, common ones may include digestive issues, changes in mood or behavior, allergic reactions if sensitive to ingredients; participants should report any discomforts they experience.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up until end of study or discontinuation (whichever occurs first), up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up until end of study or discontinuation (whichever occurs first), up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change From Baseline to Week 12 in the Aberrant Behavior Checklist-Irritability (ABC-I) Subscale Score
Secondary outcome measures
Mean Change From Baseline in the Caregiver Top 3 ABC-I Items of Concern
Mean Change From Baseline to Week 12 in Aberrant Behavior Checklist (ABC) Modified Social Withdrawal Subscale Score
Mean Change From Baseline to Week 12 in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: JZP541Experimental Treatment1 Intervention
Participants who will be randomized to receive JZP541.
Group II: PlaceboPlacebo Group1 Intervention
Participants who will be randomized to receive placebo.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism, particularly those similar to JZP541, often work by modulating neurotransmitter activity or other pathways involved in mood and behavior regulation. For instance, medications may target serotonin or dopamine receptors to help stabilize mood and reduce irritability. Oxytocin, a hormone linked to social bonding, is also being explored for its potential to improve social interactions in Autism patients. These mechanisms are crucial as they directly address core symptoms of Autism, such as irritability and social deficits, thereby improving the quality of life for patients.
Study protocol of the ASD-Net, the German research consortium for the study of Autism Spectrum Disorder across the lifespan: from a better etiological understanding, through valid diagnosis, to more effective health care.New directions in the treatment of autism spectrum disorders from animal model research.The oxytocin system in drug discovery for autism: animal models and novel therapeutic strategies.

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
249 Previous Clinical Trials
34,902 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
209 Patients Enrolled for Autism Spectrum Disorder
GW ResearchUNKNOWN

Media Library

JZP541 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05733390 — Phase 2
Autism Spectrum Disorder Research Study Groups: Placebo, JZP541
Autism Spectrum Disorder Clinical Trial 2023: JZP541 Highlights & Side Effects. Trial Name: NCT05733390 — Phase 2
JZP541 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733390 — Phase 2
~0 spots leftby Jul 2025