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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Nocturia, Daytime Sleepiness

In brief

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.

Key facts

Study ID

NCT02151253

Run by

Duke University

People needed

81

Starts

2011-05-01

Expected to finish

2015-09-01

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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