COMPLETED

Clarithromycin Mechanisms in Hypersomnia Syndromes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-09-04
Study Completion:2025-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04026958

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of idiopathic hypersomnia or narcolepsy
  2. * age 18-60
  3. * 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
  1. * other potential causes of hypersomnolence, including untreated moderate or severe sleep apnea, severe periodic limb movement disorder with arousals, uncontrolled metabolic disorders
  2. * contraindication to clarithromycin
  3. * contraindication to any of the study procedures

Contacts and Locations

Principal Investigator

Lynn Marie Trotti, MD, MSc
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Sleep Center
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-04
Study Completion Date2025-06-18

Study Record Updates

Study Start Date2019-09-04
Study Completion Date2025-06-18

Terms related to this study

Keywords Provided by Researchers

  • Neurology

Additional Relevant MeSH Terms

  • Narcolepsy Without Cataplexy
  • Idiopathic Hypersomnia
  • Narcolepsy With Cataplexy