Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Narcolepsy
In brief
The purpose of this study was to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-6552 in participants with Narcolepsy Type 1 (NT1). The effect of single MK-6552 doses were assessed initially under open-label conditions to evaluate the safety, tolerability, and PK of MK-6552. The effect of repeated MK-6552 doses (every 8 hours \[q8h\] for 7 days) were assessed under double-blind and placebo-controlled conditions.
Key facts
- Study ID
- NCT06179407
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 9
- Starts
- 2024-01-24
- Expected to finish
- 2024-10-23
- Last updated by the study team
- 2026-04-14
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Delta Waves, Inc. ( Site 0008) — Colorado Springs, Colorado, United States
- Teradan Clinical Trials, LLC ( Site 0005) — Brandon, Florida, United States
- NeuroTrials Research Inc ( Site 0006) — Atlanta, Georgia, United States
- Bogan Sleep Consultants ( Site 0001) — Columbia, South Carolina, United States
- FutureSearch Trials of Neurology ( Site 0004) — Austin, Texas, United States
Full record on ClinicalTrials.gov
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