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Flumazenil for the Treatment of Primary Hypersomnia

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ClinicalTrials.gov Identifier: NCT01183312
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : March 27, 2013
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
Georgia Research Alliance
Information provided by (Responsible Party):
Lynn Marie Trotti, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hypersomnia
Primary Hypersomnia
Idiopathic Hypersomnia
Narcolepsy Without Cataplexy
Intervention: Drug: Flumazenil

  Participant Flow

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, Georgia, 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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 5   5   10 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5 100.0%      5 100.0%      10 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 33.6  (13.3)   41.8  (18.1)   37.7  (15.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      5 100.0%      5 100.0%      10 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
 		     
United States   5   5   10 


  Outcome Measures

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) ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 6

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) ]
  Show Outcome Measure 7

8.  Secondary:   Electroencephalogram (EEG) Power   [ Time Frame: following drug administration ]
  Show Outcome Measure 8


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



Responsible Party: Lynn Marie Trotti, Emory University
ClinicalTrials.gov Identifier: NCT01183312     History of Changes
Other Study ID Numbers: IRB00044836
First Submitted: August 9, 2010
First Posted: August 17, 2010
Results First Submitted: January 11, 2013
Results First Posted: March 27, 2013
Last Update Posted: December 12, 2017