Trial · NCT01146600

Clarithromycin for the Treatment of Hypersomnia

NCT01146600, Phase 2, Completed, Lynn Marie Trotti; results first posted 2014-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clarithromycin for the Treatment of Hypersomnia. Trials, record NCT01146600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01146600

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clarithromycin for the Treatment of Hypersomnia
NCT number: NCT01146600
Status: Completed
Phases: Phase 2
Enrollment: 26 participants, actual
Lead sponsor: Lynn Marie Trotti
Conditions: Hypersomnia, Idiopathic Hypersomnia, Narcolepsy
Interventions: Clarithromycin followed by placebo, Placebo then Clarithromycin
First posted: 2010-06-17
Last updated: 2017-11-06
Results first posted: 2014-06-12

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Psychomotor Vigilance Task (PVT) Reaction Time	week 2 of each intervention	Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance). Note that the PVT provides a median of reaction times to all stimuli (\~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)
Secondary	PVT Median Reaction Time at Week 1	week 1	median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance) Note that the PVT provides a median of reaction times to all stimuli (\~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)
Secondary	PVT Number of Lapses	baseline, then after 1 week and 2 weeks on each study drug	Number of lapses (no response for \> 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.
Secondary	Epworth Sleepiness Scale	baseline, then after 1 week and 2 weeks on each study drug	Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)). ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness.
Secondary	FOSQ	baseline, then after 1 week and 2 weeks on each study drug	Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)). Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness.
Secondary	SF-36, Vitality Subscale	baseline, then after 1 week and 2 weeks on each study drug	The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)). The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality.
Secondary	PSQI	baseline, then after 1 week and 2 weeks on each study drug	Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)). Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Psychomotor Vigilance Task (PVT) Reaction Time	week 2 of each intervention	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	Msec	MEAN
SECONDARY	PVT Median Reaction Time at Week 1	week 1	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	Msec	MEAN
SECONDARY	PVT Number of Lapses	baseline, then after 1 week and 2 weeks on each study drug	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	Number of lapses	MEAN
SECONDARY	Epworth Sleepiness Scale	baseline, then after 1 week and 2 weeks on each study drug	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	units on a scale	MEAN
SECONDARY	FOSQ	baseline, then after 1 week and 2 weeks on each study drug	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	units on a scale	MEAN
SECONDARY	SF-36, Vitality Subscale	baseline, then after 1 week and 2 weeks on each study drug	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	units on a scale	MEAN
SECONDARY	PSQI	baseline, then after 1 week and 2 weeks on each study drug	Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Psychomotor Vigilance Task (PVT) Reaction Time	Clarithromycin	279.1	Standard Deviation 77.3	Msec
Psychomotor Vigilance Task (PVT) Reaction Time	Placebo	311.6	Standard Deviation 114.1	Msec
Psychomotor Vigilance Task (PVT) Reaction Time	Baseline	333.8	Standard Deviation 291.4	Msec
PVT Median Reaction Time at Week 1	Clarithromycin	285.4	Standard Deviation 71.3	Msec
PVT Median Reaction Time at Week 1	Placebo	308.4	Standard Deviation 120.6	Msec
PVT Median Reaction Time at Week 1	Baseline	333.8	Standard Deviation 291.4	Msec
PVT Number of Lapses	Clarithromycin	5.7	Standard Deviation 11.3	Number of lapses
PVT Number of Lapses	Placebo	10.3	Standard Deviation 18.7	Number of lapses
PVT Number of Lapses	Baseline	6.5	Standard Deviation 16.9	Number of lapses
Epworth Sleepiness Scale	Clarithromycin	10.1	Standard Deviation 5.4	units on a scale

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1 (Weeks 1 & 2)	STARTED	Clarithromycin, Then Placebo	13
Period 1 (Weeks 1 & 2)	STARTED	Placebo, Then Clarithromycin	10
Period 1 (Weeks 1 & 2)	COMPLETED	Clarithromycin, Then Placebo	10
Period 1 (Weeks 1 & 2)	COMPLETED	Placebo, Then Clarithromycin	10
Period 1 (Weeks 1 & 2)	NOT COMPLETED	Clarithromycin, Then Placebo	3
Period 1 (Weeks 1 & 2)	NOT COMPLETED	Placebo, Then Clarithromycin	0
Washout (Week 3)	STARTED	Clarithromycin, Then Placebo	10
Washout (Week 3)	STARTED	Placebo, Then Clarithromycin	10
Washout (Week 3)	COMPLETED	Clarithromycin, Then Placebo	10
Washout (Week 3)	COMPLETED	Placebo, Then Clarithromycin	10

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	abdominal pain	Gastrointestinal disorders	Clarithromycin	3	22
other	abdominal pain	Gastrointestinal disorders	Placebo	1	20
other	anxiety	Psychiatric disorders	Clarithromycin	1	22
other	anxiety	Psychiatric disorders	Placebo	1	20
other	bad taste or smell	General disorders	Clarithromycin	15	22
other	bad taste or smell	General disorders	Placebo	0	20
other	bloating/gas	Gastrointestinal disorders	Clarithromycin	2	22
other	bloating/gas	Gastrointestinal disorders	Placebo	1	20
other	chest discomfort	Musculoskeletal and connective tissue disorders	Clarithromycin	0	22
other	chest discomfort	Musculoskeletal and connective tissue disorders	Placebo	1	20

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Clarithromycin
Total, all-cause mortality	Placebo
Total, other adverse events	Clarithromycin	21	22
Total, other adverse events	Placebo	15	20
Total, serious adverse events	Clarithromycin	0	22
Total, serious adverse events	Placebo	0	20

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26094838	DERIVED	PubMed
34031871	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Clarithromycin vs Placebo: serious adverse events

Source Trial comparisons

Tests1

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
Psychomotor Vigilance Task	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01146600

GET https://conductscience.org/api/trials/v1/NCT01146600/results?page=2

API reference For AI assistants