Trials / Withdrawn
WithdrawnNCT05733390
A Study of JZP541 in Adults With Irritability Associated With Autism Spectrum Disorder
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Jazz Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Behavior dysregulation is commonly associated with people with autism spectrum disorder (ASD). Irritability is a major safety concern in adults with ASD. This study will assess the efficacy and safety of JZP541 in the treatment of adults with irritability associated with ASD.
Detailed description
This randomized, double-blind, placebo-controlled, phase 2 study will evaluate the efficacy and safety of JZP541 in treating irritability in adults with ASD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JZP541 | Oral suspension |
| OTHER | Placebo | Oral suspension |
Timeline
- Start date
- 2023-06-30
- Primary completion
- 2023-11-09
- Completion
- 2023-11-09
- First posted
- 2023-02-17
- Last updated
- 2024-11-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05733390. Inclusion in this directory is not an endorsement.