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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Armodafinil; Modafinil

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