Clarithromycin Mechanisms in Hypersomnia Syndromes

Completed · Phase 2 · Has a placebo group

Conditions studied: Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy

In brief

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 sleepiness, but researchers do not know how clarithromycin does this. This study will look at brain activity (on magnetic resonance imaging \[MRI\]), 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.

Key facts

Study ID

NCT04026958

Run by

Emory University

People needed

83

Starts

2019-09-04

Expected to finish

2025-06-18

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory Sleep Center — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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