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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


  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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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) ]

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


  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