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Clarithromycin for the Treatment of Hypersomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lynn Marie Trotti, Emory University
ClinicalTrials.gov Identifier:
NCT01146600
First received: June 15, 2010
Last updated: August 25, 2014
Last verified: August 2014
Results First Received: September 28, 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
Idiopathic Hypersomnia
Narcolepsy
Interventions: Drug: Clarithromycin followed by placebo
Drug: Placebo then Clarithromycin

  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
Most subjects were recruited from the patient population of a single Sleep Center affiliated with Emory University School of Medicine. One subject contacted investigators for participation after reading of the study on clinicaltrials.gov. The first patient was recruited 3/5/11 and the final patient completed the study on 9/28/12.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects underwent screening laboratories after enrollment but before beginning medication. In the case of abnormal laboratory results (n = 2), subjects did not begin treatment with either study drug (clarithromycin or placebo). One patient dropped out after consent but before randomization (because of scheduling conflict).

Reporting Groups
  Description
Clarithromycin, Then Placebo Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout)
Placebo, Then Clarithromycin Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)

Participant Flow for 3 periods

Period 1:   Period 1 (Weeks 1 & 2)
    Clarithromycin, Then Placebo     Placebo, Then Clarithromycin  
STARTED     13     10  
COMPLETED     10     10  
NOT COMPLETED     3     0  

Period 2:   Washout (Week 3)
    Clarithromycin, Then Placebo     Placebo, Then Clarithromycin  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  

Period 3:   Period 2 (Weeks 4 & 5)
    Clarithromycin, Then Placebo     Placebo, Then Clarithromycin  
STARTED     10     10  
COMPLETED     10     10  
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
Clarithromycin, Then Placebo

Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.

Clarithromycin followed by placebo : Clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks, then one week with no medication, then matched placebo po bid (with breakfast and lunch) for two weeks.

Placebo, Then Clarithromycin

Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.

Placebo then Clarithromycin : Matched placebo po bid (with breakfast and lunch) for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks

Total Total of all reporting groups

Baseline Measures
    Clarithromycin, Then Placebo     Placebo, Then Clarithromycin     Total  
Number of Participants  
[units: participants]
  13     10     23  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     10     23  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.8  ± 13.4     34.7  ± 14.5     34.2  ± 13.6  
Gender  
[units: participants]
     
Female     9     8     17  
Male     4     2     6  
Region of Enrollment  
[units: participants]
     
United States     13     10     23  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Psychomotor Vigilance Task (PVT) Reaction Time   [ Time Frame: week 2 of each intervention ]

2.  Secondary:   PVT Median Reaction Time at Week 1   [ Time Frame: week 1 ]

3.  Secondary:   PVT Number of Lapses   [ Time Frame: baseline, then after 1 week and 2 weeks on each study drug ]

4.  Secondary:   Epworth Sleepiness Scale   [ Time Frame: baseline, then after 1 week and 2 weeks on each study drug ]

5.  Secondary:   FOSQ   [ Time Frame: baseline, then after 1 week and 2 weeks on each study drug ]

6.  Secondary:   SF-36, Vitality Subscale   [ Time Frame: baseline, then after 1 week and 2 weeks on each study drug ]

7.  Secondary:   PSQI   [ Time Frame: baseline, then after 1 week and 2 weeks on each study drug ]

8.  Secondary:   Reported Adverse Events   [ Time Frame: baseline, week 1, week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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: Lynn Marie Trotti, MD, MSc
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: NCT01146600     History of Changes
Other Study ID Numbers: IRB00044170
Study First Received: June 15, 2010
Results First Received: September 28, 2013
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board