Clarithromycin Mechanisms in Hypersomnia Syndromes

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate a medication called clarithromycin for treating sleepiness in two related conditions, narcolepsy without cataplexy and idiopathic hypersomnia. Studies have shown that clarithromycin can reduce sleepiness, but researchers do not know how clarithromycin does this. This study will look at brain activity (on magnetic resonance imaging [MRI] and electroencephalogram [EEG] brainwaves), inflammation, bacteria living in the gut, and cerebrospinal fluid, to better understand how clarithromycin can reduce sleepiness. This study will recruit 92 participants who will be randomized to receive clarithromycin or a placebo for 14 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
• Treatments: Clarithromycin

Criteria

Inclusion Criteria:

• diagnosis of idiopathic hypersomnia or narcolepsy type 2

• age 18-45 (with the upper limit established because of age-dependent changes in DMN resting state functional magnetic resonance imaging connectivity (rs-fMRI) connectivity and to minimize risk of side effects)

• free of wake-promoting medication or willing to discontinue current wake-promoting medication for at least 5 half-lives prior to baseline measures

• free of pre- or probiotic supplements for at least six months prior to baseline measures

Exclusion Criteria:

• other potential causes of hypersomnolence, including moderate or severe sleep apnea, severe periodic limb movement disorder with arousals, uncontrolled metabolic disorders, hypocretin deficiency, or cataplexy

• contraindication to clarithromycin

• contraindication to any of the study procedures