Using clarithromycin to treat excessive sleepiness in narcolepsy and idiopathic hypersomnia
Antibiotic-mediated Improvements in Vigilance: Mechanisms of Action of Clarithromycin in Hypersomnia Syndromes
This study is testing if the antibiotic clarithromycin can help reduce daytime sleepiness in people with narcolepsy and idiopathic hypersomnia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04026958 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of clarithromycin in reducing excessive daytime sleepiness associated with narcolepsy and idiopathic hypersomnia. It aims to understand the mechanisms behind clarithromycin's effects by examining brain activity through MRI, inflammation, gut bacteria, and cerebrospinal fluid. A total of 92 participants will be randomized to receive either clarithromycin or a placebo for a duration of 14 days. The study seeks to address the unmet need for effective treatments in patients who do not respond adequately to current therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-60 diagnosed with idiopathic hypersomnia or narcolepsy who are not currently using wake-promoting medications or are willing to discontinue them.
Not a fit: Patients with other causes of hypersomnolence, such as untreated sleep apnea or severe metabolic disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from excessive daytime sleepiness due to hypersomnia syndromes.
How similar studies have performed: Previous studies have shown that clarithromycin can significantly improve sleepiness and related quality of life in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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 this trial is running
Atlanta, Georgia
- Emory Sleep Center — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Lynn Marie Trotti, MD, MSc — Emory University
- Study coordinator: Tyler Blake
- Email: tyler.j.blake@emory.edu
- Phone: 404-778-6114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.