Trial · NCT01183312

Flumazenil for the Treatment of Primary Hypersomnia

NCT01183312, Phase 1, Phase 2, Completed, Lynn Marie Trotti; results first posted 2013-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Flumazenil for the Treatment of Primary Hypersomnia. Trials, record NCT01183312. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183312

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Trial

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

Title: Flumazenil for the Treatment of Primary Hypersomnia
NCT number: NCT01183312
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Lynn Marie Trotti
Conditions: Hypersomnia, Primary Hypersomnia, Idiopathic Hypersomnia, Narcolepsy Without Cataplexy
Interventions: Flumazenil
First posted: 2010-08-17
Last updated: 2017-12-12
Results first posted: 2013-03-27
Limitations and caveats: EEG power was specified as a secondary outcome measure. Second-by-second manual artifact removal has been necessary to ensure interpretable data. This artifact removal is in progress and results will be reported separately.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Change in Psychomotor Vigilance Task (PVT) Median Reaction Time	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	The PVT measures the reaction time to button press following the presentation of a visual stimulus, reported here as the median reaction time for multiple presentations during the 10 minute task. The measure used was the change in median reaction time from baseline to drug administration, where the median reaction time at each of the time points (below) was averaged to provide a single on-treatment value for median reaction time. The measure was then calculated as baseline value - treatment value, such that higher numbers denote improvement from baseline.
Secondary	PVT Additional Measure #1, Change in Lapse Frequency	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	A PVT lapse is defined as a reaction time exceeding 500 msec following the presentation of a single stimulus, which are then summed for the entire 10 minute PVT testing period. The measure used was the change in the frequency of lapses from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).
Secondary	PVT Additional Measure #2, Change in Duration of Lapse Domain	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	The PVT duration of lapse domain is defined as the reciprocal of the reaction time averaged across the slowest 10% of responses. The measure used was the change in duration of lapse domain from baseline to drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).
Secondary	PVT Additional Measure #3, Change in Optimum Response Times	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	The optimum response times is defined as the reciprocal of the reaction time averaged across the fastest 10% of responses. The measure used was the change in optimum response time from baseline to following drug administration (calculated as baseline value - average value with study drug, where lower numbers denote improvement from baseline).
Secondary	PVT Additional Measure #4, Change in False Response Frequency	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	The false response frequency is defined as the number of button presses when no stimulus is presented. The measure used was the change in false response frequency from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).
Secondary	PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	At the end of the 10 minute PVT testing period, subjects were asked to rate their current level of sleepiness along a line, which was transformed into a numeric value from 1-10, such that high levels indicated more severe subjective sleepiness. The measure used was the change in this rating from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).
Secondary	Change in Stanford Sleepiness Scale	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	The Stanford Sleepiness Scale (SSS) is a subjective rating of sleepiness, with score ranging from 1 to 7, where higher values reflect more severe sleepiness. The measure used was change in SSS from baseline to drug administration (calculated as baseline value - average value with study drug, where higher numbers denote improvement from baseline).
Secondary	Electroencephalogram (EEG) Power	following drug administration	EEG signals reflect the state of excitability of the cerebral cortex and correlate highly with levels of behavioral arousal. This is quantifiable as 'power' of the signal (microvolts squared/signal frequency). The EEG signals will be acquired and stored for off-line power analysis and comparison between treatment conditions.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Psychomotor Vigilance Task (PVT) Median Reaction Time	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	msec	MEAN
SECONDARY	PVT Additional Measure #1, Change in Lapse Frequency	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	number of lapses during PVT testing	MEAN
SECONDARY	PVT Additional Measure #2, Change in Duration of Lapse Domain	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	1/msec	MEAN
SECONDARY	PVT Additional Measure #3, Change in Optimum Response Times	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	1/msec	MEAN
SECONDARY	PVT Additional Measure #4, Change in False Response Frequency	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	number of false starts	MEAN
SECONDARY	PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	units on a scale	MEAN
SECONDARY	Change in Stanford Sleepiness Scale	10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject)	Intention to treat (all randomized subjects were included)	units on a scale	MEAN
SECONDARY	Electroencephalogram (EEG) Power	following drug administration	EEG signal processing analyses have not been performed. This would require an additional set of extensive analyses, very distinct from the statistics performed for the other study outcomes. EEG data were collected for possible future analyses, pending resources and expertise, and as such we have no data to report here.

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
Change in Psychomotor Vigilance Task (PVT) Median Reaction Time	Placebo	-9.86	Standard Deviation 28.2	msec
Change in Psychomotor Vigilance Task (PVT) Median Reaction Time	Sublingual Flumazenil	-4.46	Standard Deviation 63.7	msec
PVT Additional Measure #1, Change in Lapse Frequency	Placebo	-3.3	Standard Deviation 6.9	number of lapses during PVT testing
PVT Additional Measure #1, Change in Lapse Frequency	Sublingual Flumazenil	-2.6	Standard Deviation 8.7	number of lapses during PVT testing
PVT Additional Measure #2, Change in Duration of Lapse Domain	Placebo	0.18	Standard Deviation 0.30	1/msec
PVT Additional Measure #2, Change in Duration of Lapse Domain	Sublingual Flumazenil	0.25	Standard Deviation 0.45	1/msec
PVT Additional Measure #3, Change in Optimum Response Times	Placebo	-0.02	Standard Deviation 0.27	1/msec
PVT Additional Measure #3, Change in Optimum Response Times	Sublingual Flumazenil	-0.04	Standard Deviation 0.63	1/msec
PVT Additional Measure #4, Change in False Response Frequency	Placebo	0.09	Standard Deviation 0.56	number of false starts
PVT Additional Measure #4, Change in False Response Frequency	Sublingual Flumazenil	-0.38	Standard Deviation 0.45	number of false starts

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention Day	STARTED	Placebo First, Then Flumazenil	5
First Intervention Day	STARTED	Flumazenil First, Then Placebo	5
First Intervention Day	COMPLETED	Placebo First, Then Flumazenil	5
First Intervention Day	COMPLETED	Flumazenil First, Then Placebo	5
First Intervention Day	NOT COMPLETED	Placebo First, Then Flumazenil	0
First Intervention Day	NOT COMPLETED	Flumazenil First, Then Placebo	0
Washout Period of at Least 1 Week	STARTED	Placebo First, Then Flumazenil	5
Washout Period of at Least 1 Week	STARTED	Flumazenil First, Then Placebo	5
Washout Period of at Least 1 Week	COMPLETED	Placebo First, Then Flumazenil	5
Washout Period of at Least 1 Week	COMPLETED	Flumazenil First, Then Placebo	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events14

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	feeling dizzy, lightheaded, or spacey	Nervous system disorders	Placebo	4	10
other	feeling dizzy, lightheaded, or spacey	Nervous system disorders	Sublingual Flumazenil	3	10
other	headache (during or following drug administration)	Nervous system disorders	Placebo	0	10
other	headache (during or following drug administration)	Nervous system disorders	Sublingual Flumazenil	4	10
other	feeling jittery	Nervous system disorders	Placebo	0	10
other	feeling jittery	Nervous system disorders	Sublingual Flumazenil	1	10
other	feeling of panic, anxiety, or uneasy	Psychiatric disorders	Placebo	1	10
other	feeling of panic, anxiety, or uneasy	Psychiatric disorders	Sublingual Flumazenil	1	10
other	back pain	Musculoskeletal and connective tissue disorders	Placebo	0	10
other	back pain	Musculoskeletal and connective tissue disorders	Sublingual Flumazenil	1	10

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Sublingual Flumazenil
Total, other adverse events	Placebo	4	10
Total, other adverse events	Sublingual Flumazenil	9	10
Total, serious adverse events	Placebo	0	10
Total, serious adverse events	Sublingual Flumazenil	0	10

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Sublingual Flumazenil 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/NCT01183312

GET https://conductscience.org/api/trials/v1/NCT01183312/registered

API reference For AI assistants