MK-6552 for Narcolepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment called MK-6552 for people with Narcolepsy Type 1 (NT1), a sleep disorder marked by excessive daytime sleepiness and sudden muscle weakness (cataplexy). The study will first determine the drug's safety and tolerability with different doses in a single day, then evaluate its effects over several days. Participants will be divided into groups, with some receiving the actual medication and others a placebo (inactive substance). The trial seeks individuals diagnosed with NT1 who have experienced cataplexy, can sleep more than 6 hours on most nights, and do not have certain health conditions like high blood pressure or heart issues. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that MK-6552 is likely to be safe for humans?
Research shows that MK-6552 remains in the early testing stages for people with narcolepsy. In these initial studies, researchers focus on how well participants tolerate MK-6552, monitoring for any health changes or unusual lab results. As a new treatment, detailed safety information is limited. However, these early trials help determine if MK-6552 is safe enough for further testing at higher doses or over longer periods. Ensuring participant safety is a top priority, and researchers will closely monitor and address any serious side effects.12345
Why do researchers think this study treatment might be promising?
Unlike traditional treatments for narcolepsy, which often include stimulants like modafinil or sodium oxybate, MK-6552 offers a novel approach by potentially providing quicker relief. Researchers are excited because MK-6552 is taken orally and its effects can be tailored based on individual safety and tolerability, potentially making it more adaptable than current options. Additionally, MK-6552's dosing flexibility could mean that patients experience benefits in just a single day, which is a significant advantage over existing therapies that might take longer to show results.
What evidence suggests that MK-6552 might be an effective treatment for narcolepsy?
Research has shown that MK-6552, which participants in this trial may receive, might help people with narcolepsy stay awake. In earlier studies, MK-6552 proved more effective than a placebo at keeping sleep-deprived healthy people awake. This suggests the drug could also benefit those with narcolepsy. Although early results on MK-6552's effects in people with narcolepsy are still emerging, its ability to help healthy individuals stay awake is promising. More research is needed to confirm its effectiveness for narcolepsy.12356
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Dose Escalation
Participants receive single oral doses of MK-6552 in ascending fashion approximately 6 hours apart for a single day to evaluate safety, tolerability, and pharmacokinetics.
Part 2: Multiple-Day Dosing
Participants receive multiple days of MK-6552 or placebo dosing (7 consecutive days) to investigate pharmacodynamics.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- MK-6552
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
In Part 2, participants will receive multiple days of placebo dosing (7 consecutive days).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
Study of MK-6552 in Participants With Narcolepsy Type 1 ...
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.
2.
trial.medpath.com
trial.medpath.com/clinical-trial/333e48c56448f4fe/nct06179407-safety-tolerability-pharmacokinetics-mk-6552-narcolepsyStudy of MK-6552 in Participants With Narcolepsy Type 1 (MK ...
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy ...
A Study of MK-6552 in Sleep Deprived Healthy Participants ...
This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in ...
Trial | NCT06179407
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy ...
Study of MK-6552 in Participants With Narcolepsy Type 1
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy ...
6.
ctv.veeva.com
ctv.veeva.com/study/study-of-mk-6552-in-participants-with-narcolepsy-type-1-mk6552004Study of MK-6552 in Participants With Narcolepsy Type 1 (MK ...
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants ...
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