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Macrolide Antibiotic
Clarithromycin for Excessive Daytime Sleepiness
Phase 2
Recruiting
Led By Lynn Marie Trotti, MD, MSc
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of idiopathic hypersomnia or narcolepsy
diagnosis of idiopathic hypersomnia or narcolepsy type 2
Must not have
Contraindication to clarithromycin
Other potential causes of hypersomnolence, including untreated moderate or severe sleep apnea, severe periodic limb movement disorder with arousals, uncontrolled metabolic disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -2, day 13
Summary
This trial is testing clarithromycin, an antibiotic, to see if it can help people with narcolepsy and idiopathic hypersomnia who struggle with excessive sleepiness. Researchers will study how it affects brain signals, body inflammation, and gut bacteria. Clarithromycin has shown potential in improving sleepiness in previous trials.
Who is the study for?
This trial is for adults aged 18-60 with narcolepsy or idiopathic hypersomnia who are either not taking wake-promoting meds, can stop them safely before the study, or still feel sleepy on these meds. They shouldn't have taken pre/probiotic supplements for six months and must not have other sleep disorders or conditions that could explain their sleepiness.
What is being tested?
Researchers are testing clarithromycin against a placebo to see if it reduces sleepiness in those with narcolepsy and idiopathic hypersomnia. The study will also explore how this drug affects brain activity, inflammation, gut bacteria, and cerebrospinal fluid by using MRI scans among other methods.
What are the potential side effects?
Clarithromycin may cause side effects like digestive issues (nausea, diarrhea), changes in taste sensation, headaches, and rarely more serious conditions such as allergic reactions or liver problems. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with idiopathic hypersomnia or narcolepsy.
Select...
I have been diagnosed with idiopathic hypersomnia or narcolepsy type 2.
Select...
I am between 18 and 60 years old.
Select...
I am between 18 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot take clarithromycin due to health reasons.
Select...
I do not have untreated sleep apnea, severe limb movement disorder, or uncontrolled metabolic disorders causing excessive sleepiness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day -2, day 13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day -2, day 13
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Default Mode Network (DMN) Connectivity
Change in Epworth Sleepiness Scale Score
Change in Maintenance of Wakefulness Test (MWT)
+3 moreSecondary study objectives
Change in Fatigue Severity Scale (FSS) Score
Change in Functional Outcomes of Sleep Questionnaire (FOSQ) Score
Change in Hypersomnia Severity Index (HSI)
+15 moreSide effects data
From 2021 Phase 3 trial • 1046 Patients • NCT041676705%
Diarrhoea
1%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vonoprazan Dual Therapy
Vonoprazan Triple Therapy
Lansoprazole Triple Therapy
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClarithromycinExperimental Treatment1 Intervention
Participants in this study arm will receive clarithromycin for 14 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this study arm will receive a placebo to match clarithromycin for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clarithromycin
2017
Completed Phase 4
~3950
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Clarithromycin, being studied for Idiopathic Hypersomnia, may reduce sleepiness by modulating brain activity, inflammation, gut microbiota, and cerebrospinal fluid. This is important for IH patients as it targets potential underlying causes of their excessive daytime sleepiness.
Other common treatments, such as modafinil, work by increasing dopamine levels to promote wakefulness. Understanding these mechanisms helps in tailoring treatments to improve the quality of life for IH patients by reducing sleepiness and enhancing cognitive function.
Clarithromycin in γ-aminobutyric acid-Related hypersomnolence: A randomized, crossover trial.[Wake disorders. I. Primary wake disorders].
Clarithromycin in γ-aminobutyric acid-Related hypersomnolence: A randomized, crossover trial.[Wake disorders. I. Primary wake disorders].
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,688 Previous Clinical Trials
2,602,853 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
44 Patients Enrolled for Idiopathic Hypersomnia
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,371 Previous Clinical Trials
650,781 Total Patients Enrolled
Lynn Marie Trotti, MD, MSc4.29 ReviewsPrincipal Investigator - Emory University
Emory University
1 Previous Clinical Trials
44 Total Patients Enrolled
1 Trials studying Idiopathic Hypersomnia
44 Patients Enrolled for Idiopathic Hypersomnia
5Patient Review
Dr. So-and-so is very knowledgeable about sleep disorders and easy to communicate with. I appreciate that she values my input in regards to how my care progresses.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't take wake-promoting meds, or I'm willing to stop them before the study starts.I cannot take clarithromycin due to health reasons.I do not have untreated sleep apnea, severe limb movement disorder, or uncontrolled metabolic disorders causing excessive sleepiness.I have been diagnosed with idiopathic hypersomnia or narcolepsy.You have not taken pre- or probiotic supplements for at least six months before the study starts.I have been diagnosed with idiopathic hypersomnia or narcolepsy type 2.I am between 18 and 60 years old.I am between 18 and 60 years old.I don't take wake-promoting meds, or I'm willing to stop them before the study starts.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Clarithromycin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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