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Trial record 17 of 241 for:    (armodafinil)

Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

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ClinicalTrials.gov Identifier: NCT02151253
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nocturia
Daytime Sleepiness
Interventions Drug: Armodafinil
Drug: Placebo
Enrollment 81
Recruitment Details Eighty-one individuals signed consent and were screened for entry into this study. Thirty of these subjects met the inclusion/exclusion criteria but only 28 subjects were randomized to the study. (2 subjects withdrew consent prior to randomization).
Pre-assignment Details  
Arm/Group Title Armodafinil First, Then Placebo Placebo First, Then Armodafinil
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During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.

Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.

During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.

Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.

Period Title: Overall Study
Started 13 15
Completed 13 15
Not Completed 0 0
Arm/Group Title All Randomized Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Between 18 and 90 Number Analyzed 28 participants
54.5  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
21
  75.0%
Male
7
  25.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants
African American 17
Caucasian 9
Asian 1
Mixed Race 1
1.Primary Outcome
Title Change From Baseline in Epworth Sleepiness Scale [ESS]
Hide Description Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.
Time Frame Baseline, Week 4 of each phase
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo
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Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.03  (5.18) 9.73  (4.43)
2.Secondary Outcome
Title Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
Hide Description Scale consists of a 7 point likert rating scale where the anchors were 1= ”normal”; 2= ”borderline sleepiness”; 3= ”mild sleepiness”; 4= ”moderate sleepiness”; 5= ”marked sleepiness”; 6= ”severe sleepiness”; and 7= ”among the most extremely sleepy individuals”
Time Frame week 4, of each phase
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.58  (1.03) 3.12  (0.82)
3.Secondary Outcome
Title Mean Number of Naps/Day
Hide Description measurements are for the preceding week
Time Frame week 4 of each phase.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: naps per day
0.48  (0.71) 0.73  (1.20)
4.Secondary Outcome
Title Mean Number of Minutes Napped Per Day Based on Sleep Diary
Hide Description measurements are for the preceding week
Time Frame week 4 of each phase.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: minutes napped per day
38.9  (65.1) 40.0  (61.3)
5.Secondary Outcome
Title Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Hide Description Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Time Frame week 4 of each phase.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Overall Number of Participants Analyzed 28 28
Mean (Standard Deviation)
Unit of Measure: Nocturic Events
1.6  (1.1) 1.89  (1.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
All-Cause Mortality
Armodafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Armodafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/28 (39.29%)   10/28 (35.71%) 
Gastrointestinal disorders     
Nausea  1/28 (3.57%)  1/28 (3.57%) 
General disorders     
Dizziness  0/28 (0.00%)  1/28 (3.57%) 
Psychiatric disorders     
Anxiety/Jitteriness  4/28 (14.29%)  3/28 (10.71%) 
insomnia  1/28 (3.57%)  0/28 (0.00%) 
Renal and urinary disorders     
Urinary Tract Infection  0/28 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection  4/28 (14.29%)  4/28 (14.29%) 
Sinus Infection  1/28 (3.57%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  0/28 (0.00%)  1/28 (3.57%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew D. Krystal, MD, MS
Organization: Duke University Health System
Phone: 919-971-4355
EMail: andrew.krystal@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02151253     History of Changes
Other Study ID Numbers: Pro00028116
First Submitted: May 28, 2014
First Posted: May 30, 2014
Results First Submitted: July 25, 2016
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017