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

Nocturia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Nocturia

Daytime Sleepiness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ArmodafinilArmodafinil 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:PlaceboSubject 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

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Armodafinil First, Then PlaceboDuring 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.

Placebo First, Then ArmodafinilDuring 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.

Study Status

Completed

Start Date: May 2011

Completed Date: September 2015

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Change From Baseline in Epworth Sleepiness Scale [ESS]

Secondary Outcome: Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)

Study sponsors, principal investigator, and references

Principal Investigator: Andrew Krystal, MD

Lead Sponsor: Duke University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02151253

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