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

Duke University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Daytime Sleepiness; Nocturia

Treatments: Drug: Placebo; Drug: Armodafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT02151253

Pro00028116

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

Armodafinil First, Then Placebo

Experimental group

Description:

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.

Treatment:

Drug: Armodafinil

Drug: Placebo

Placebo First, Then Armodafinil

Placebo Comparator group

Description:

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.

Treatment:

Drug: Armodafinil

Drug: Placebo