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

NCT02151253 | Completed Phase 2 Results

• 1 other identifier: Pro00028116
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nocturia; Daytime Sleepiness

Keywords

Nocturia; Daytime sleepiness

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Epworth Sleepiness Scale [ESS]

  Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.

  Baseline, Week 4 of each phase

Secondary Outcomes (4)

• Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)

  week 4, of each phase

• Mean Number of Naps/Day

  week 4 of each phase.

• Mean Number of Minutes Napped Per Day Based on Sleep Diary

  week 4 of each phase.

• Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)

  week 4 of each phase.

Study Arms (2)

Armodafinil First, Then Placebo

EXPERIMENTAL

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.

Drug: Armodafinil; Drug: Placebo

Placebo First, Then Armodafinil

PLACEBO COMPARATOR

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.

Drug: Armodafinil; Drug: Placebo

Interventions

Armodafinil DRUG

Armodafinil 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.

Armodafinil First, Then Placebo; Placebo First, Then Armodafinil

Placebo DRUG

Subject 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.

Armodafinil First, Then Placebo; Placebo First, Then Armodafinil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Nocturia; Disorders of Excessive Somnolence

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Andrew D. Krystal, MD, MS
• Organization: Duke University Health System

andrew.krystal@duke.edu

919-971-4355

Study Officials

• Andrew Krystal, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: May 30, 2014
• Study Start: May 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 24, 2017
• Results First Posted: March 24, 2017

Record last verified: 2017-03

Locations

US (1)