What side effects are associated with this type of intervention?

Common treatments for narcolepsy, such as modafinil, pitolisant, and suvorexant, have various side effects. Modafinil is generally well-tolerated but can cause headaches. Pitolisant may lead to insomnia and anxiety. Suvorexant, used for insomnia but relevant due to its sedative properties, can cause somnolence and headache. These side effects are important considerations when evaluating the safety and efficacy of treatments like MK-6552 for narcolepsy.

What prior FDA approvals exist?

The FDA has approved several treatments for narcolepsy, focusing on their safety, efficacy, pharmacokinetics, and pharmacodynamics. Sodium oxybate is approved for treating cataplexy and excessive daytime sleepiness in narcolepsy patients, demonstrating significant improvements in nighttime sleep and quality of life. Pitolisant, another FDA-approved drug, is effective in reducing cataplexy and excessive daytime sleepiness by acting as a histamine H3 receptor antagonist/inverse agonist. These treatments are similar to the investigational drug MK-6552, which is being studied for its safety and efficacy in Narcolepsy Type 1.

What other types of research exist?

Promising, novel alternatives to MK-6552 for Narcolepsy Type 1 patients in 2024 may include pharmacologic agents that target respiratory drive, upper airway collapsibility, and noradrenergic systems. Additionally, cannabinoid-based treatments like dronabinol, which have shown potential in sleep disorder management, could be considered.

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Orexin Receptor Antagonist

MK-6552 for Narcolepsy

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is positive for HLA-DQB1*06:02 allele supporting a diagnosis of NT1

Be between 18 and 65 years old

Must not have

Has a history of seizure disorder, clinically significant head trauma, or past invasive intracranial surgery or clinically significant dementia

Has history of or current hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 dose 1: predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose 1. day 1 dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose

Summary

This trial tests a new drug, MK-6552, for safety and effectiveness in people with Narcolepsy Type 1. It aims to understand how the drug behaves in the body and its impact on the sleep disorder.

Who is the study for?

This trial is for individuals with Narcolepsy Type 1 (NT1), who have had a valid sleep study in the last 5 years and been diagnosed with NT1 for at least 6 months. They must sleep over 6 hours on most nights and be positive for a specific genetic marker (HLA-DQB1*06:02). Participants should also have a history of cataplexy before starting any related medications.

What is being tested?

The trial is testing MK-6552, which could potentially treat NT1. The first part checks how safe it is and how the body processes different doses in one day. The second part looks at how well it works after taking it once or multiple times across several days. Some participants will receive a placebo instead to compare results.

What are the potential side effects?

While the side effects are not detailed here, common ones may include reactions where the drug enters the body, changes in alertness, stomach issues, or headaches. Side effects can vary widely from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have the HLA-DQB1*06:02 allele, indicating narcolepsy type 1.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures, significant head injury, brain surgery, or serious memory loss.

Select...

I have high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 dose 1: predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose 1. day 1 dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 dose 1: predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose 1. day 1 dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 dose 1: predose, 0.25, 0.5, 1, 2, 3, 4, and 6 hours postdose 1. day 1 dose 2: 0.25, 0.5, 1, 2, 3, 4, 6, 8, 18, 21 and 24 hours postdose for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants discontinuing study intervention due to an Adverse Event (AE)

Number of participants experiencing an Adverse Event (AE)

Sleep Onset Latency Measured by the Maintenance of Wakefulness Test (MWT)

Secondary study objectives

Apparent Oral Clearance (CL/F) of MK-6552

Apparent Terminal Half-life (t½) of MK-6552

Apparent Volume of Distribution (Vz/F) of MK-6552

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-6552Experimental Treatment1 Intervention

In Part 1, participants will receive single oral doses of MK-6552 in ascending fashion approximately 6 hours apart for a single day, based on safety and tolerability of the previous dose. In Part 2, participants will receive multiple days of MK-6552 dosing (7 consecutive days) at the highest safe and well tolerated MK-6552 dose determined on an individual basis from Part 1.

Group II: PlaceboPlacebo Group1 Intervention

In Part 2, participants will receive multiple days of placebo dosing (7 consecutive days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-6552

2024

Completed Phase 1

~50

0 / 3Eligibility criteria met

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 Narcolepsy, such as dexamphetamine and sodium oxybate, work by targeting the neurotransmitters involved in sleep-wake regulation. Dexamphetamine increases dopamine and norepinephrine levels to promote wakefulness, while sodium oxybate enhances slow-wave sleep and reduces cataplexy through GABA-B receptor activation. These mechanisms are essential for managing excessive daytime sleepiness and cataplexy, the primary symptoms of Narcolepsy, thereby improving the quality of life for patients. Treatments like MK-6552, under investigation, likely follow similar pathways to address these symptoms effectively.

Analysis of Daily Sleep Diary Measures From Multilayer Extended-Release Methylphenidate (PRC-063) Studies in Children and Adults With ADHD.Pharmacologic Treatments for Sleep Disorders in Children: A Systematic Review.Treatment in the narcoleptic syndrome: self assessment of the action of dexamphetamine and clomipramine.