Flumazenil for the Treatment of Primary Hypersomnia

This study has been completed.

Sponsor:

Collaborator:

Georgia Research Alliance

Information provided by (Responsible Party):

Lynn Marie Trotti, Emory University

ClinicalTrials.gov Identifier:

NCT01183312

First received: August 9, 2010

Last updated: November 13, 2013

Last verified: November 2013

History of Changes

Results First Received: January 11, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Hypersomnia Primary Hypersomnia Idiopathic Hypersomnia Narcolepsy Without Cataplexy
Intervention:	Drug: Flumazenil

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the Sleep Center of the Emory Clinic, in Atlanta, GA, USA, between December 2010 and October 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 patients were enrolled; of these, 2 were excluded prior to randomization because screening laboratory test results were abnormal.

Reporting Groups

	Description
Placebo First, Then Flumazenil	Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.
Flumazenil First, Then Placebo	Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.

Participant Flow for 3 periods

Period 1: First Intervention Day

	Placebo First, Then Flumazenil	Flumazenil First, Then Placebo
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Period 2: Washout Period of at Least 1 Week

	Placebo First, Then Flumazenil	Flumazenil First, Then Placebo
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Period 3: Second Intervention Day

	Placebo First, Then Flumazenil	Flumazenil First, Then Placebo
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Placebo First, Then Flumazenil	Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).
Flumazenil First, Then Placebo	Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).
Total	Total of all reporting groups

Baseline Measures

	Placebo First, Then Flumazenil	Flumazenil First, Then Placebo	Total
Number of Participants [units: participants]	5	5	10
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	5	5	10
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	33.6 ± 13.3	41.8 ± 18.1	37.7 ± 15.6
Gender [units: participants]
Female	5	5	10
Male	0	0	0
Region of Enrollment [units: participants]
United States	5	5	10

Outcome Measures

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1. Primary:

Change in Psychomotor Vigilance Task (PVT) Median Reaction Time [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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2. Secondary:

PVT Additional Measure #1, Change in Lapse Frequency [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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3. Secondary:

PVT Additional Measure #2, Change in Duration of Lapse Domain [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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4. Secondary:

PVT Additional Measure #3, Change in Optimum Response Times [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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5. Secondary:

PVT Additional Measure #4, Change in False Response Frequency [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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6. Secondary:

PVT Additional Measure #5, Change in Visual Analog Scale Rating of Sleepiness at the Completion of PVT [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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7. Secondary:

Change in Stanford Sleepiness Scale [ Time Frame: 10, 30, 60, 90, 120, and 150 minutes after drug administration (averaged for all time points for each subject) ]

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8. Secondary:

EEG Power [ Time Frame: following drug administration ]

Results not yet reported. Anticipated Reporting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Lynn Marie Trotti
Organization: Emory University School of Medicine
phone: 404-728-4752
e-mail: lbecke2@emory.edu

No publications provided

Responsible Party:	Lynn Marie Trotti, Emory University
ClinicalTrials.gov Identifier:	NCT01183312 History of Changes
Other Study ID Numbers:	IRB00044836
Study First Received:	August 9, 2010
Results First Received:	January 11, 2013
Last Updated:	November 13, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

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