Flumazenil for the Treatment of Primary Hypersomnia
This study has been completed.
Sponsor:
Lynn Marie Trotti
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
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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
Hide 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, 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
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
Show All 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: | EEG Power [ Time Frame: following drug administration ] |
Results not yet reported. Anticipated Reporting Date:
No text entered.
Safety Issue:
No
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:
Results Point of Contact:
| 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
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 |
| 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 |