Clarithromycin Mechanisms in Hypersomnia Syndromes

Description

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.

Conditions

Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy

Study Overview

Study Details

Study overview

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.

Antibiotic-mediated Improvements in Vigilance: Mechanisms of Action of Clarithromycin in Hypersomnia Syndromes

Clarithromycin Mechanisms in Hypersomnia Syndromes

Condition
Narcolepsy Without Cataplexy
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory Sleep Center, Atlanta, Georgia, United States, 30329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Emory University,

Lynn Marie Trotti, MD, MSc, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2025-03-01