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
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) ]

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:   EEG Power   [ Time Frame: following drug administration ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame Symptoms experienced within 24 hours of drug administration
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Placebo No text entered.
Sublingual Flumazenil No text entered.

Other Adverse Events
    Placebo     Sublingual Flumazenil  
Total, other (not including serious) adverse events      
# participants affected / at risk     4/10     9/10  
Musculoskeletal and connective tissue disorders      
back pain      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)  
Nervous system disorders      
feeling "dizzy", "lightheaded", or "spacey"      
# participants affected / at risk     4/10 (40.00%)     3/10 (30.00%)  
headache (during or following drug administration)      
# participants affected / at risk     0/10 (0.00%)     4/10 (40.00%)  
feeling "jittery"      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)  
Psychiatric disorders      
feeling of "panic", "anxiety", or "uneasy"      
# participants affected / at risk     1/10 (10.00%)     1/10 (10.00%)  
feeling "giggly" or "high"      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)  
feeling dysphoria or "drugged"      
# participants affected / at risk     0/10 (0.00%)     1/10 (10.00%)  



  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