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Study Summary
This trial will study if a drug, JZP541, can help adults with autism spectrum disorder who have irritability, a major safety concern.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had a seizure in the last 2 years.You have been diagnosed with a serious mental health condition like schizophrenia or bipolar disorder with psychotic features.You have a history of mental disorders that affect your thoughts and perception, or you have close family members who have been diagnosed with similar conditions.You have had a heart attack or serious heart problems within the past year, or you have a history of significant artery-related diseases like stroke or heart disease.You have thought about hurting yourself or have tried to hurt yourself in the past month.You have frequent episodes of anger, aggression, or hurting yourself or others that affect your ability to function or impact those around you.You are currently taking bupropion.You have been evaluated by a doctor and they have determined that your irritability is moderate (at least a 3 on a scale of 1 to 7).You have a history of alcohol or drug problems.
- Group 1: Placebo
- Group 2: JZP541
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants in this investigation under the age of twenty eligible to take part?
"To qualify for this clinical trial, patients must fall within the 18-45 age bracket. Separately, there are 257 trials available to those under 18 and 48 options for individuals older than 65."
Has the Food and Drug Administration given authorization for JZP541?
"Our team at Power assigned JZP541 a safety rating of 2, since this is merely a Phase 2 trial. This indicates that there are some studies attesting to the medication's safety but no evidence in support of its efficacy yet."
Are there available slots in this research trial for participants?
"Affirmative. According to the data posted on clinicaltrials.gov, this medical study is actively seeking participants since June 30th 2023 and was last updated August 2nd of that same year. The trial requires 90 volunteers from one single centre."
How many individuals have been enrolled in this clinical trial so far?
"Affirmative. The clinical trial registry on clinicaltrials.gov verifies that recruitment of patients has started for this medical study, which was initially published on June 30th 2023 and latest updated on August 2nd 2023. 90 individuals need to be admitted at a single site."
Is it possible to join this research endeavor?
"This clinical trial is seeking 90 participants between 18 and 45 years of age who have been clinically diagnosed with autism spectrum disorder. To qualify, they must also possess a suitable study companion, comprehend the assessments to be completed in the trial adequately, communicate effectively with research staff, comply with all protocol regulations, exhibit sufficient literacy for questionnaires assigned by the protocol team. Furthermore, medication compliance is mandatory as well as abstaining from donating sperm or using contraception during treatment period extending 12 weeks post-intervention. The candidate's intelligence quotient (IQ) or General Ability Index (GAI), assessed through Wechsler Adult Intelligence Scale - Fourth Edition"
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