Status:
COMPLETED
Clarithromycin Mechanisms in Hypersomnia Syndromes
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Narcolepsy Without Cataplexy
Idiopathic Hypersomnia
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in narcolepsy and idiopathic hypersomnia. Studies have shown that clarithromycin can reduce sleepine...
Detailed Description
Excessive daytime sleepiness and long sleep durations are common features of many neurologic disorders, including myotonic dystrophy, Parkinson's disease, and the central nervous system hypersomnia sy...
Eligibility Criteria
Inclusion
- diagnosis of idiopathic hypersomnia or narcolepsy
- age 18-60
- free of wake-promoting medication, sleepy despite current wake-promoting medications, or willing to discontinue current wake-promoting medication for at least 5 half-lives prior to baseline measures
Exclusion
- other potential causes of hypersomnolence, including untreated moderate or severe sleep apnea, severe periodic limb movement disorder with arousals, uncontrolled metabolic disorders
- contraindication to clarithromycin
- contraindication to any of the study procedures
Key Trial Info
Start Date :
September 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2025
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT04026958
Start Date
September 4 2019
End Date
June 18 2025
Last Update
July 16 2025
Active Locations (1)
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1
Emory Sleep Center
Atlanta, Georgia, United States, 30329