Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 240 for:    (armodafinil)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE May 30, 2014
Results First Submitted Date  ICMJE July 25, 2016
Results First Posted Date  ICMJE March 24, 2017
Last Update Posted Date March 24, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
Change From Baseline in Epworth Sleepiness Scale [ESS] [ Time Frame: Baseline, Week 4 of each phase ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Change in Epworth Sleepiness Scale [ Time Frame: Week 2, Week 4, of each phase ]
Change in Epworth score.
Change History Complete list of historical versions of study NCT02151253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS) [ Time Frame: week 4, of each phase ]
    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 [ Time Frame: week 4 of each phase. ]
    measurements are for the preceding week
  • Mean Number of Minutes Napped Per Day Based on Sleep Diary [ Time Frame: week 4 of each phase. ]
    measurements are for the preceding week
  • Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep) [ Time Frame: week 4 of each phase. ]
    Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS) [ Time Frame: Week 2, week 4, of each phase ]
  • Number of naps [ Time Frame: Baseline; week 4 of each phase. ]
  • Number of minutes napped based on sleep diary [ Time Frame: Baseline; week 4 of each phase. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nocturia
  • Daytime Sleepiness
Intervention  ICMJE
  • 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.
  • Drug: 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.
Study Arms  ICMJE
  • Experimental: Armodafinil First, Then Placebo

    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.

    Interventions:
    • Drug: Armodafinil
    • Drug: Placebo
  • Placebo Comparator: Placebo First, Then Armodafinil

    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.

    Interventions:
    • Drug: Armodafinil
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2017)
81
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2014)
30
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02151253
Other Study ID Numbers  ICMJE Pro00028116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Krystal, MD Duke University
PRS Account Duke University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP