Status:
COMPLETED
Clarithromycin for the Treatment of Hypersomnia
Lead Sponsor:
Lynn Marie Trotti
Conditions:
Hypersomnia
Idiopathic Hypersomnia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The term 'hypersomnia' describes a group of symptoms that includes severe daytime sleepiness and sleeping long periods of time (more than 10 hours per night). Sometimes, hypersomnia is caused by a pro...
Detailed Description
Central hypersomnias are characterized by severe excessive daytime sleepiness despite long sleep periods (\>10 hours/night) and the absence of nocturnal sleep pathology. They preferentially affect you...
Eligibility Criteria
Inclusion
- Hypersomnia (meeting clinical criteria for Idiopathic hypersomnia with or without long sleep time, narcolepsy lacking cataplexy, or symptomatic hypersomnia not meeting ICSD criteria)
- evidence for GABA-related abnormality, as demonstrated by in-house, in vitro assay
- age \> 18
- high performance liquid chromatography/liquid chromatography tandem mass spectrometry verification of the absence of exogenous benzodiazepines
Exclusion
- Contraindications to use of clarithromycin (pregnancy, severe renal impairment, history of QT prolongation, hypomagnesemia, hypokalemia, bradycardia, history of myocardial infarction or cardiomyopathy, myasthenia gravis, age \> 70)
- Current use of cisapride, pimozide, astemizole, terfenadine, colchicines, and ergotamine or dihydroergotamine
- Current use of benzodiazepines or benzodiazepine-receptor agonists
- moderate or severe sleep apnea (RDI \> 15/hr), severe periodic limb movement disorder (PLMI \> 30/hr)
- diagnosis of narcolepsy with cataplexy, as determined by cerebrospinal hypocretin levels
- metabolic disorders such as anemia, severe iron deficiency, B12 deficiency, or hypothyroidism that may explain symptoms of hypersomnia
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01146600
Start Date
July 1 2010
End Date
September 1 2012
Last Update
November 6 2017
Active Locations (1)
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1
Emory Sleep Center
Atlanta, Georgia, United States, 30329