Status:
TERMINATED
Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Narcolepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1). Part 1 will evaluate safety, to...
Eligibility Criteria
Inclusion
- Has a diagnosis of NT1, including a valid polysomnography within the previous 5 years and a current diagnosis of NT1 for at least 6 months based on criteria established by the International Classification of Sleep Disorders- Third Edition, or Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) \[American Psychiatric Association 2013\]
- Is positive for HLA-DQB1\*06:02 allele supporting a diagnosis of NT1
- Has a baseline history of unequivocal cataplexy prior to initiation of anti-cataplexy medications
- Reports a total sleep time of \> 6 hours on at least 4 out of 7 nights each week within the 4 weeks prior to screening visit
Exclusion
- Has history of or current hypertension
- Has underlying cardiovascular or cerebrovascular conditions in which an acute rise in blood pressure would pose a clinical concern, including but nor limited to aneurysms or arteriovenous malformations
- Has a history of renal or hepatic impairment
- Has a history of cardiac ischemia or cerebral ischemia including but not limited to history of stroke, transient ischemic attack, or transient global amnesia
- Based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale, is at imminent risk of self-harm or of harm to others in the opinion of the investigator
- Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
- History of cancer (malignancy)
- Has a history of any of the following sleep disorders: obstructive sleep apnea (OSA) defined as an Apnea Hypopnea Index \> 15 per hour per the American Academy of Sleep Medicine alternate criteria, primary insomnia (within the past 6 months), circadian rhythm sleep disorder, shift work sleep disorder (within the past 6 months), clinically significant parasomnia at the discretion of the investigator
- Has a history of seizure disorder, clinically significant head trauma, or past invasive intracranial surgery or clinically significant dementia
- Positive test(s) for Hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06179407
Start Date
January 24 2024
End Date
October 23 2024
Last Update
March 20 2025
Active Locations (5)
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1
Delta Waves, Inc. ( Site 0008)
Colorado Springs, Colorado, United States, 80918
2
Teradan Clinical Trials, LLC ( Site 0005)
Brandon, Florida, United States, 33511
3
NeuroTrials Research Inc ( Site 0006)
Atlanta, Georgia, United States, 30328
4
Bogan Sleep Consultants ( Site 0001)
Columbia, South Carolina, United States, 29201