What side effects are associated with this type of intervention?

Common treatments for narcolepsy and hypersomnolence disorders, such as modafinil, sodium oxybate, and pitolisant, have various side effects. Modafinil is generally well-tolerated but can cause headaches, nausea, and anxiety. Sodium oxybate may lead to nausea, dizziness, and enuresis. Pitolisant's side effects include insomnia, headache, and anxiety. These treatments aim to improve wakefulness and reduce cataplexy, similar to the investigational drug JZP441.

What prior FDA approvals exist?

Several FDA-approved drugs are used to treat narcolepsy and related hypersomnolence disorders, focusing on wake-promoting and anticataplectic effects. Sodium oxybate is approved for treating cataplexy and excessive daytime sleepiness in narcolepsy. Pitolisant, a histamine H3 receptor antagonist/inverse agonist, is also approved for excessive daytime sleepiness and cataplexy in narcolepsy. Additionally, modafinil and armodafinil are wake-promoting agents approved for narcolepsy, obstructive sleep apnea, and shift work sleep disorder. These treatments share similar therapeutic goals with JZP441, which is under investigation for its wake-promoting and anticataplectic properties.

What other types of research exist?

Promising alternatives to JZP441 for wake-promoting and anticataplectic activity include modafinil and armodafinil, which have been used effectively in treating sleepiness in obstructive sleep apnea. These agents are well-studied and have demonstrated efficacy in promoting wakefulness.

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Unknown

JZP441 Safety Study in Healthy Participants

Phase 1

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 pre-dose and multiple post-dose timepoints, up to day 28

Summary

This trial is testing a new drug called JZP441, which helps people stay awake and prevents sudden muscle weakness. It is aimed at people with narcolepsy and hypersomnolence disorders who struggle with these symptoms. The study will check the safety and effectiveness of the drug in healthy adults over a short period.

Who is the study for?

This trial is for healthy adults aged 18-50 with no gastrointestinal, liver, or kidney diseases that could affect drug processing. They must not have a history of substance abuse in the past two years and should not be using any medications that lower seizure threshold.

What is being tested?

The study tests JZP441's safety and how it's processed by the body when given in increasing doses to healthy participants. It compares JZP441 against a placebo to see if it can help people with narcolepsy without causing harm.

What are the potential side effects?

Potential side effects are not detailed here but will likely include monitoring for common drug-related issues such as digestive disturbances, changes in heart rhythm or blood pressure, allergic reactions, and neurological symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and multiple post-dose timepoints, up to day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and multiple post-dose timepoints, up to day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and multiple post-dose timepoints, up to day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Proportionality of JZP441 for Area Under the Concentration-Time Curve (AUC)

Dose Proportionality of JZP441 for Maximum Concentration (Cmax)

Pharmacokinetic Parameter Accumulation Ratio of JZP441

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: JZP441Experimental Treatment1 Intervention

Healthy participants who will be randomized to receive an oral dose of JZP441.

Group II: PlaceboPlacebo Group1 Intervention

Healthy participants who will be randomized to receive placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JZP441

2022

Completed Phase 1

~130

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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 wake-promoting and anticataplectic activity, such as modafinil and orexin receptor agonists, work by enhancing neurotransmitter activity in the brain. Modafinil increases dopamine availability, promoting wakefulness and alertness, while orexin receptor agonists mimic orexin neuropeptides to prevent cataplexy and maintain wakefulness. These mechanisms are important for healthy subjects to ensure optimal cognitive and physical performance by preventing excessive daytime sleepiness and sudden muscle weakness.

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