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

Nocturia Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151253
• Other study ID #: Pro00028116
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 28, 2014
• Last updated: March 22, 2017
• Start date: May 2011
• Est. completion date: September 2015

Study information

• Verified date: March 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Receiving standard-of-care therapy for nocturia based on assessment by study physician

2. Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.

3. Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary

4. Epworth Sleepiness Scale Score of at least 10

5. Clinical Global Impression of Sleepiness at least Moderate

6. Age 18-90 years inclusive

Exclusion Criteria:

1. Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment

2. Sleep disorders other than nocturia based on history and screening assessment

3. Unstable medical or psychiatry conditions

4. Medical or psychiatric conditions affecting sleep/wake or urologic function

5. Apnea-Hypopnea Index (AHI) = 15 on screening polysomnogram

6. Periodic Leg Movement Arousal Index (PLMAI) = 15 on screening polysomnogram

7. History of substance abuse or dependence in the last year

8. Regular consumption of over 800 mg of caffeine use

9. Shift-work in the 3 months prior to or during the study

Related Conditions & MeSH terms

• Daytime Sleepiness
• Nocturia

Intervention

Drug:
• Armodafinil
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 4 of each phase
Secondary	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"	week 4, of each phase
Secondary	Mean Number of Naps/Day	measurements are for the preceding week	week 4 of each phase.
Secondary	Mean Number of Minutes Napped Per Day Based on Sleep Diary	measurements are for the preceding week	week 4 of each phase.
Secondary	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	week 4 of each phase.