Trial · NCT04026958
Clarithromycin Mechanisms in Hypersomnia Syndromes
NCT04026958, Phase 2, Completed, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clarithromycin Mechanisms in Hypersomnia Syndromes. Trials, record NCT04026958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04026958
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clarithromycin Mechanisms in Hypersomnia Syndromes
- NCT number
- NCT04026958
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Narcolepsy Without Cataplexy, Idiopathic Hypersomnia, Narcolepsy With Cataplexy
- Interventions
- Clarithromycin, Placebo
- First posted
- 2019-07-19
- Last updated
- 2026-08-07
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Epworth Sleepiness Scale (ESS) Score | Day -1, Day 14 | The Epworth Sleepiness Scale asks participants to respond to 8 scenarios with how likely they are to fall asleep on a 4-point scale where 0 = "would never doze" and 3 = "high chance of dozing". Total scores range from 0 to 24 where higher scores indicate a higher chance of falling asleep during daytime activities. The change in ESS score is obtained by subtracting the total score at Day 14 from the baseline score. Scores above 0 mean that the mean score at Day 14 was lower than the mean score at Baseline, indicating less sleepiness. |
| Primary | Change in Maintenance of Wakefulness Test (MWT) for Sleep Latency | Day -1, Day 14 | The MWT polysomnographic procedure for sleep latency examines how well participants stay awake during several trials where participants relax in a quiet room for 40 minutes. One study found the mean sleep latency among persons without a sleep disorder to be 35.2 minutes. The change from baseline is calculated as baseline sleep latency minus sleep latency at Day 14, in minutes. Positive values result when the duration of sleep latency at Day 14 is lower than at Baseline. |
| Primary | Change in Gamma-aminobutyric Acid Receptor A (GABA-A) Potentiation | Day -1, Day 14 | Cerebrospinal fluid (CSF) is drawn to determine the change in levels of GABA-A potentiation between the study arms. The difference between measured current with GABA alone and the current measured with GABA + CSF yields a measure of potentiation for each CSF sample in each condition. The change from baseline is calculated as the baseline value minus the value at Day 14. |
| Primary | Change in Default Mode Network (DMN) Connectivity | Day -2, Day 13 | The default mode network (DMN) consists of a group of highly correlated brain regions most active during quiet rest, while the task positive network (TPN) is the brain network activated for goal-directed tasks. DMN connectivity changes with sleep states and it is increasingly implicated in the symptomatology of sleepiness. During resting state, sleep deprived participants demonstrate reduced static connectivity with the DMN. Changes in DMN between the Baseline 1 (Day - 2) and Day 13 visits are compared between treatment groups, particularly using quasi-periodic patterns (QPPs), which interrogate network-level connectivity on a dynamic scale. Preservation of the temporal dimension provides more insight into how this spatiotemporal network propagates across condition and pathology. The DMN/TPN QPP correlation is reported. |
| Primary | Change in Tumor Necrosis Factor - Alpha (TNF-α) | Day -1, Day 14 | Blood samples are used to determine the change in levels of TNF-α between the study arms. TNF-α is a soporific cytokine and a reduction in soporific cytokines is hypothesized to reduce daytime sleepiness. |
| Primary | Change in Gastrointestinal Microbiome Composition | Day -1, Day 14 | Changes in microbiome composition, as measured by alpha diversity using the Shannon Index, via 16S ribosomal ribonucleic acid (rRNA) sequencing results are compared between study arms. The Shannon Index measures both abundance and evenness of microbial species, values of 0 indicate that a community has only one species. The higher the value the higher the diversity of species in a particular community. Change from baseline is calculated by subtracting the Day 14 value from the value at Baseline. Numbers greater than 0 indicate that the Day 14 Shannon index value is lower than at Baseline. |
| Secondary | On-Treatment Sleep Duration | Day 1 through Day 14 | Participants log when they go to bed and when they wake up in order to calculate the number of minutes spent sleeping. The average duration of sleep across 14 days is compared between study arms. |
| Secondary | Change in Fatigue Severity Scale (FSS) Score | Day -1, Day 14 | Fatigue severity is measured with the Fatigue Severity Scale (FSS). The FSS is a 9-item instrument where responses are on a scale of 1 to 7 where 1 = "disagree" and 7 = "agree". Total scores range from 9 to 63 where higher scores indicate greater fatigue. The change in FSS score is obtained by subtracting the total score at Day 14 from the Baseline score. Scores above 0 signify that the mean score at Day 14 was lower than the mean score at Baseline, indicating decreased fatigue. |
| Secondary | Change in Multidimensional Fatigue Inventory (MFI-20) Score | Day -1, Day 14 | The MFI-20 is a 20-item instrument assessing fatigue severity. Responses are on a 5-point scale where 1 = "yes, that is true" and 5 = "no, that is not true". Positively phrased items are reverse scored so that the total score ranges from 20 to 100 where higher scores indicate greater severity of fatigue. The change in MFI-20 score is obtained by subtracting the total score at Day 14 from the Baseline score. Scores above 0 signify that the mean score at Day 14 was lower than the mean score at Baseline, indicating decreased fatigue. |
| Secondary | Change in Sleep Inertia Questionnaire (SIQ) Score | Day -1, Day 14 | The SIQ is an instrument with 21 items with responses on a 5-point scale where 1 = "not at all" and 5 = "all the time". Two additional questions relate to how much time it takes for the respondent to wake up in the morning. Total scores range from 21 to 105 and higher scores indicate increased difficulty from tiredness. The change in SIQ score is obtained by subtracting the total score at Day 14 from the baseline score. Scores above 0 signify that the mean score at Day 14 was lower than the mean score at Baseline, indicating reduced difficulty awakening. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS111280 | Antibiotic-mediated improvements in vigilance: mechanisms of action of clarithromycin in hypersomnia syndromes | TROTTI, LYNN MARIE | EMORY UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04026958
GET https://conductscience.org/api/trials/v1/NCT04026958/registered?page=2