What side effects are associated with this type of intervention?

Common side effects for treatments similar to JZP441, which are likely sleep or wakefulness modulators, include somnolence, dizziness, headache, and fatigue. For example, eszopiclone and zopiclone, both used for sleep disorders, commonly cause somnolence and next-day drowsiness. Sodium oxybate, used for narcolepsy, can also cause dizziness and headache. These side effects are generally mild to moderate in severity.

What prior FDA approvals exist?

Prior FDA approvals for treatments similar to JZP441, which likely modulates sleep or wakefulness, include JZP-110, sodium oxybate, and pitolisant. JZP-110 has been shown to significantly improve wakefulness in narcolepsy patients. Sodium oxybate is approved for treating cataplexy and disrupted nighttime sleep in narcolepsy. Pitolisant is another approved drug that effectively manages narcolepsy symptoms. These drugs have undergone rigorous clinical trials demonstrating their efficacy and safety in modulating sleep and wakefulness.

What other types of research exist?

Promising, novel alternatives to JZP441 for healthy subjects considering treatment in 2024 include flumazenil for hypersomnolence and modafinil for narcolepsy. Additionally, USL261 (intranasal midazolam) may be considered for its improved bioavailability and pharmacodynamic effects.

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JZP441 for Sleep Deprivation

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 up to 5 years

Summary

This trial tests a new drug called JZP441 to see if it is safe and how it works in the body. The study involves healthy people who haven't had enough sleep. Participants will take the drug, and researchers will monitor its effects and how it moves through their bodies.

Who is the study for?

Healthy adults aged 18-50 can join this trial. They must pass a medical exam, including lab tests and heart monitoring, and not be pregnant or nursing. People with kidney issues, abnormal ECGs, significant allergies, mental health disorders like bipolar or schizophrenia, certain infections (HIV/hepatitis), chronic insomnia, major cardiovascular diseases or those who've recently been in other drug/device trials cannot participate.

What is being tested?

The study is testing JZP441 against a placebo in sleep-deprived healthy people to see how safe it is and how the body reacts to different doses at night. It's a Phase 1 trial where participants are randomly assigned to get either the real drug or a fake pill without knowing which one they're taking.

What are the potential side effects?

Since this is an early-phase trial for JZP441 in healthy individuals deprived of sleep, specific side effects aren't listed yet. Generally speaking though, potential side effects could include reactions at the site of administration (if applicable), changes in alertness levels or mood disturbances given its nature as a central nervous system-active compound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: JZP441Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Participants who will be randomized to receive an oral dose of placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JZP441

2022

Completed Phase 1

~130

Do I qualify?Apply below to find out

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 sleep or wakefulness modulation, such as JZP441, often work by targeting neurotransmitter systems in the brain. For example, modafinil, a well-known wakefulness-promoting agent, increases dopamine levels by inhibiting its reuptake. This enhances alertness and cognitive function. Understanding these mechanisms is crucial for healthy subjects as it helps in predicting potential side effects, optimizing dosing schedules, and ensuring the safety and efficacy of the treatment. This knowledge is particularly important in clinical trials to ensure that the benefits outweigh any risks for participants.

[Precision medicine in pediatric neurology exemplified by the new treatment forms].Central Nervous System Trial Failures: Using the Fragile X Syndrome-mGluR5 Drug Target to Highlight the Complexities of Translating Preclinical Discoveries Into Human Trials.Cancer treatment-related neuropathic pain syndromes--epidemiology and treatment: an update.