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Clarithromycin for the Treatment of Hypersomnia

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ClinicalTrials.gov Identifier: NCT01146600
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : June 12, 2014
Last Update Posted : November 6, 2017
Sponsor:
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
Idiopathic Hypersomnia
Narcolepsy
Interventions Drug: Clarithromycin followed by placebo
Drug: Placebo then Clarithromycin
Enrollment 26
Recruitment Details 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 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).
Arm/Group Title Clarithromycin, Then Placebo Placebo, Then Clarithromycin
Hide Arm/Group Description Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout) Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)
Period Title: Period 1 (Weeks 1 & 2)
Started 13 10
Completed 10 10
Not Completed 3 0
Period Title: Washout (Week 3)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Period 2 (Weeks 4 & 5)
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Clarithromycin, Then Placebo Placebo, Then Clarithromycin Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 13 10 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
10
 100.0%
23
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 10 participants 23 participants
33.8  (13.4) 34.7  (14.5) 34.2  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 10 participants 23 participants
Female
9
  69.2%
8
  80.0%
17
  73.9%
Male
4
  30.8%
2
  20.0%
6
  26.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 10 participants 23 participants
13 10 23
1.Primary Outcome
Title Psychomotor Vigilance Task (PVT) Reaction Time
Hide Description

Median reaction time on the PVT at the end of the second week of treatment. Lower values reflect faster reaction times (I.e., greater vigilance).

Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 2, placebo week 2)

Time Frame week 2 of each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: Msec
279.1  (77.3) 311.6  (114.1) 333.8  (291.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method ANOVA
Comments ANOVA, comparing baseline, clarithromycin, and placebo
2.Secondary Outcome
Title PVT Median Reaction Time at Week 1
Hide Description

median reaction time on the PVT at week 1 of each intervention. Lower values reflect faster reaction times (i.e., better vigilance)

Note that the PVT provides a median of reaction times to all stimuli (~100) presented during the 10 minute PVT test. Each subject had two PVT tests at each visit, resulting in two median values. These were averaged, and then, for the purposes of this outcome, we then obtained the MEAN across multiple subjects for each condition (baseline, clarithromycin week 1, placebo week 1)

Time Frame week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: Msec
285.4  (71.3) 308.4  (120.6) 333.8  (291.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method ANOVA
Comments ANOVA comparing baseline, clarithromycin, and placebo
3.Secondary Outcome
Title PVT Number of Lapses
Hide Description Number of lapses (no response for > 500 msec) on the PVT, averaged by subject across all administrations for a given drug condition (i.e. administered twice at baseline, four times on clarithromycin (twice during week 1 and twice during week 2), and four times on placebo (twice during week 1 and twice during week 2)). Higher numbers indicate worse vigilance.
Time Frame baseline, then after 1 week and 2 weeks on each study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: Number of lapses
5.7  (11.3) 10.3  (18.7) 6.5  (16.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method ANOVA
Comments ANOVA comparing baseline, clarithromycin, and placebo
4.Secondary Outcome
Title Epworth Sleepiness Scale
Hide Description

Scores on the Epworth Sleepiness Scale (ESS) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).

ESS scores can range from 0 to 24. Higher scores indicate higher levels of sleepiness.

Time Frame baseline, then after 1 week and 2 weeks on each study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.1  (5.4) 14.1  (3.7) 15.0  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments ANOVA comparing baseline, clarithromycin, and placebo
5.Secondary Outcome
Title FOSQ
Hide Description

Scores on the Functional Outcomes of Sleep Questionnaire (FOSQ) were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).

Scores on the FOSQ can range from 5 to 20. Higher FOSQ scores indicate less impairment due to sleepiness.

Time Frame baseline, then after 1 week and 2 weeks on each study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.6  (2.4) 14.4  (2.7) 13.9  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments ANOVA comparing baseline, clarithromycin, and placebo
6.Secondary Outcome
Title SF-36, Vitality Subscale
Hide Description

The SF-36 is a health outcome scale with multiple subsections. Subjects were administered the entire SF-36; this analysis is of the vitality subscore provided by this scale. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered once at baseline, twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).

The vitality subscore is calculated using four questions from the SF-36, and can range from 0 to 100. Higher scores reflect more vitality.

Time Frame baseline, then after 1 week and 2 weeks on each study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.9  (26.9) 28.0  (22.5) 25.0  (21.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANOVA
Comments ANOVA comparing baseline, clarithromycin, and placebo
7.Secondary Outcome
Title PSQI
Hide Description

Scores on the Pittsburgh Sleep Quality Index (PSQI), a questionnaire based assessment of sleep quality. Scores were averaged by subject across all administrations for a given drug condition (i.e. administered twice on clarithromycin (once during week 1 and once during week 2) and twice on placebo (once during week 1 and once during week 2)).

Scores on the PSQI can range from 0 to 21. Higher scores indicate poorer sleep quality.

Time Frame baseline, then after 1 week and 2 weeks on each study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on all subjects who took both study drugs (i.e., clarithromycin and placebo)
Arm/Group Title Clarithromycin Placebo Baseline
Hide Arm/Group Description:
Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
Matched placebo with breakfast and with lunch for two weeks
Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.8  (3.9) 6.3  (2.8) 6.7  (3.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin, Placebo, Baseline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method ANOVA
Comments ANOVA comparing baseline, clarithromycin, and placebo
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clarithromycin Placebo
Hide Arm/Group Description Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks Matched placebo with breakfast and with lunch for two weeks
All-Cause Mortality
Clarithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clarithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clarithromycin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/22 (95.45%)   15/20 (75.00%) 
Cardiac disorders     
syncope *  0/22 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders     
abdominal pain *  3/22 (13.64%)  1/20 (5.00%) 
bloating/gas *  2/22 (9.09%)  1/20 (5.00%) 
diarrhea *  4/22 (18.18%)  5/20 (25.00%) 
change in appetite (increase or decrease) *  2/22 (9.09%)  1/20 (5.00%) 
nausea *  7/22 (31.82%)  3/20 (15.00%) 
unspecified gastrointestinal distress *  5/22 (22.73%)  5/20 (25.00%) 
General disorders     
bad taste or smell *  15/22 (68.18%)  0/20 (0.00%) 
hiccups *  0/22 (0.00%)  1/20 (5.00%) 
sweating, flushing, or feeling hot *  2/22 (9.09%)  1/20 (5.00%) 
nose bleed *  2/22 (9.09%)  0/20 (0.00%) 
Infections and infestations     
symptoms of upper respiratory infection *  0/22 (0.00%)  3/20 (15.00%) 
Musculoskeletal and connective tissue disorders     
chest discomfort *  0/22 (0.00%)  1/20 (5.00%) 
knee pain *  0/22 (0.00%)  1/20 (5.00%) 
Nervous system disorders     
dizziness *  1/22 (4.55%)  1/20 (5.00%) 
feeling "jittery" or "hyper" *  3/22 (13.64%)  1/20 (5.00%) 
headache *  3/22 (13.64%)  5/20 (25.00%) 
insomnia *  6/22 (27.27%)  3/20 (15.00%) 
tremor *  1/22 (4.55%)  1/20 (5.00%) 
Psychiatric disorders     
anxiety *  1/22 (4.55%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: Lynn Marie Trotti, Emory University
ClinicalTrials.gov Identifier: NCT01146600     History of Changes
Other Study ID Numbers: IRB00044170
First Submitted: June 15, 2010
First Posted: June 17, 2010
Results First Submitted: September 28, 2013
Results First Posted: June 12, 2014
Last Update Posted: November 6, 2017