Status:
COMPLETED
Flumazenil for the Treatment of Primary Hypersomnia
Lead Sponsor:
Lynn Marie Trotti
Collaborating Sponsors:
Georgia Research Alliance
Conditions:
Hypersomnia
Primary Hypersomnia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Hypersomnia (meeting clinical criteria for idiopathic hypersomnia with or without long sleep time, narcolepsy lacking cataplexy, or symptomatic hypersomnia not meeting International Classification of Sleep Disorders 2 (ICSD-2) criteria inclusive of habitually long sleep periods of \> 10 hours/day)
- evidence for GABA-related abnormality, as demonstrated by our in-house, in vitro assay
- age \> 18
- high performance liquid chromatography/liquid chromatography tandem mass spectrometry verification of the absence of exogenous benzodiazepines (BZDs).
Exclusion
- Contraindications to use of flumazenil (pregnancy, hepatic impairment, seizure history, pre-menstrual dysphoric disorder, traumatic brain injury, cardiac disease (left ventricular diastolic dysfunction), or cardiac dysrrhythmia.
- Current use of a BZD or BZD-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 ICSD-2 criteria and confirmed by absence of cerebrospinal fluid (CSF) hypocretin
- metabolic disorders such as severe anemia, adrenal insufficiency, severe iron deficiency, vitamin B12 deficiency, or hypothyroidism that may explain symptoms of hypersomnia
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01183312
Start Date
September 1 2010
End Date
January 1 2012
Last Update
December 12 2017
Active Locations (1)
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1
Emory Sleep Center
Atlanta, Georgia, United States, 30329