Phase 3
N=28
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Nocturia · Daytime Sleepiness
Bottom Line
View on ClinicalTrials.gov: NCT02151253 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline in Epworth Sleepiness Scale [ESS] — 9.03; 9.73 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Armodafinil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Epworth Sleepiness Scale [ESS] |
9.03; 9.73 | — |
| SECONDARY Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS) |
2.58; 3.12 | — |
| SECONDARY Mean Number of Naps/Day |
0.48; 0.73 | — |
| SECONDARY Mean Number of Minutes Napped Per Day Based on Sleep Diary |
38.9; 40.0 | — |
| SECONDARY Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep) |
1.6; 1.89 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02151253). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.