Back to resultsCross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Primary Purpose
Nocturia, Daytime Sleepiness
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Armodafinil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nocturia focused on measuring Nocturia, Daytime sleepiness
Eligibility Criteria
Inclusion Criteria:
- Receiving standard-of-care therapy for nocturia based on assessment by study physician
- Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
- Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
- Epworth Sleepiness Scale Score of at least 10
- Clinical Global Impression of Sleepiness at least Moderate
- Age 18-90 years inclusive
Exclusion Criteria:
- Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
- Sleep disorders other than nocturia based on history and screening assessment
- Unstable medical or psychiatry conditions
- Medical or psychiatric conditions affecting sleep/wake or urologic function
- Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
- Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
- History of substance abuse or dependence in the last year
- Regular consumption of over 800 mg of caffeine use
- Shift-work in the 3 months prior to or during the study
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Armodafinil First, Then Placebo
Placebo First, Then Armodafinil
Arm Description
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Epworth Sleepiness Scale [ESS]
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.
Secondary Outcome Measures
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
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"
Mean Number of Naps/Day
measurements are for the preceding week
Mean Number of Minutes Napped Per Day Based on Sleep Diary
measurements are for the preceding week
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02151253
Brief Title
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Official Title
A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Daytime Sleepiness
Keywords
Nocturia, Daytime sleepiness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Armodafinil First, Then Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo First, Then Armodafinil
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Epworth Sleepiness Scale [ESS]
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
Secondary Outcome Measure Information:
Title
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
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
Title
Mean Number of Naps/Day
Description
measurements are for the preceding week
Time Frame
week 4 of each phase.
Title
Mean Number of Minutes Napped Per Day Based on Sleep Diary
Description
measurements are for the preceding week
Time Frame
week 4 of each phase.
Title
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving standard-of-care therapy for nocturia based on assessment by study physician
Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
Epworth Sleepiness Scale Score of at least 10
Clinical Global Impression of Sleepiness at least Moderate
Age 18-90 years inclusive
Exclusion Criteria:
Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
Sleep disorders other than nocturia based on history and screening assessment
Unstable medical or psychiatry conditions
Medical or psychiatric conditions affecting sleep/wake or urologic function
Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
History of substance abuse or dependence in the last year
Regular consumption of over 800 mg of caffeine use
Shift-work in the 3 months prior to or during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Krystal, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
We'll reach out to this number within 24 hrs