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Trial record 17 of 239 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

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.

Condition or disease Intervention/treatment Phase
Nocturia Daytime Sleepiness Drug: Armodafinil Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Study Start Date : May 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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"

  2. Mean Number of Naps/Day [ Time Frame: week 4 of each phase. ]
    measurements are for the preceding week

  3. Mean Number of Minutes Napped Per Day Based on Sleep Diary [ Time Frame: week 4 of each phase. ]
    measurements are for the preceding week

  4. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151253


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Andrew Krystal, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02151253     History of Changes
Other Study ID Numbers: Pro00028116
First Posted: May 30, 2014    Key Record Dates
Results First Posted: March 24, 2017
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by Duke University:
Nocturia
Daytime sleepiness

Additional relevant MeSH terms:
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Modafinil
Sleepiness
Nocturia
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action