What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Idiopathic Hypersomnia, such as stimulants (e.g., modafinil) and wakefulness-promoting agents, can have side effects including headache, nausea, anxiety, and insomnia. Clarithromycin, which is being studied for its potential benefits in reducing sleepiness, may cause gastrointestinal disturbances, taste alterations, and, less commonly, liver enzyme abnormalities. Lithium, another treatment option, can lead to side effects like tremor, increased thirst, diarrhea, and subclinical hypothyroidism. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Idiopathic Hypersomnia, including stimulants like modafinil and armodafinil, which promote wakefulness by affecting brain activity. These drugs are somewhat similar to clarithromycin in that they modulate brain activity, although they do not specifically target inflammation, gut microbiota, or cerebrospinal fluid. Other treatments include sodium oxybate, which helps improve sleep quality and reduce daytime sleepiness. While clarithromycin is being studied for its broader effects, current FDA-approved treatments primarily focus on enhancing wakefulness and managing sleep patterns.

What other types of research exist?

Promising novel alternatives to clarithromycin for idiopathic hypersomnia patients include curcumin and boswellia extracts, hypericum extract, and ashwagandha. These substances have shown potential in modulating inflammation, gut microbiota, and cognitive functions, which may be beneficial for managing idiopathic hypersomnia.

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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 below

Select...

I have been diagnosed with idiopathic hypersomnia or narcolepsy.

Select...

I have been diagnosed with idiopathic hypersomnia or narcolepsy type 2.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -2, day 13 for reporting.

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 more

Secondary 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 more

Side effects data

From 2021 Phase 3 trial • 1046 Patients • NCT04167670

Diarrhoea

Dysgeusia

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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].

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,708 Previous Clinical Trials

2,607,392 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,385 Previous Clinical Trials

652,596 Total Patients Enrolled

Lynn Marie Trotti, MD, MSc4.29 ReviewsPrincipal Investigator - Emory University

Emory University

1 Previous Clinical Trials

44 Total Patients Enrolled

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.