We are enrolling research participants into a medication study, testing the medication clarithromycin for the treatment of narcolepsy (types 1 & 2) and idiopathic hypersomnia
| We want to answer 2 questions: 1) Does clarithromycin treat sleepiness in people with narcolepsy or idiopathic hypersomnia? 2) In people whose symptoms get better with clarithromycin, how is clarithromycin working? To advance scientific understanding of narcolepsy and idiopathic hypersomnia and help develop new treatment options |
| WHO CAN PARTICIPATE? PARTICIPANTS MUST: 1)Have a diagnosis of idiopathic hypersomnia, narcolepsy type 1 (with cataplexy), or narcolepsy type 2 (without cataplexy) 2) Be ages 18-60 ALSO, PARTICIPANTS MUST EITHER: 1) Be sleepy despite taking medications to treat their narcolepsy or hypersomnia, OR 2) Be willing to lower or stop their wake-promoting medications for approximately 3 weeks, during the study PARTICIPANTS CANNOT HAVE: 1) A history of heart disease 2) Untreated moderate or severe sleep apnea, or other causes of sleepiness 3) Allergy to clarithromycin or other medical reasons not to take clarithromycin |
| WHAT IS INVOLVED? There are five study visits total, four of which are in person, in Atlanta, GA Visit 1 (phone, zoom, or in-person): discussion, completion of paperwork, and discussion of medical history Visit 2 (in-person): Brain MRI. This visit takes approximately 2 hours Visit 3 (in-person, the day after Visit 2): All day (approximately 7 am to 5 pm) in the Emory Sleep Lab. During this visit, participants will undergo a test to determine their ability to remain awake, complete questionnaires, and provide stool and blood samples. At the end of this visit, there is an optional spinal tap. After Visit 3, participants will randomly be assigned to take either clarithromycin or placebo for two weeks, but neither the study team nor the participant will know who is taking which. Visit 4 (in-person): Occurs two weeks after Visit 2, and is the same as Visit 2 Visit 5 (in-person): Occurs two weeks after Visit 3, and is the same as Visit 3 |
| ARE THERE COSTS? IS THERE COMPENSATION? Study medication and all study procedures are provided at no cost, other than routine expenses like transportation. Participants who complete all study visits will be compensated $400 for their time |
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| WHAT ARE THE RISKS? All research studies have risks. Clarithromycin is a medication that has been in use in the United States as an antibiotic for approximately thirty years, so it is not a new medication. However, it has not been studied extensively in people with narcolepsy or hypersomnia. Known serious but very rare risks include increased mortality in people with heart disease (people with heart disease are excluded from participating in the study) and changes in the bacteria in the body that can allow serious infections to develop. The study procedures are generally low risk. The optional spinal tap carries a risk of headache and back pain, as well as very rare, more serious risks like damage to nerves or bleeding. |
HOW DO I FIND OUT MORE OR SIGN UP?
| Phone | 404-778-6114 Email | Sleep [dot] research [at] emory [dot] edu |
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