NocturiaPhase 2/3NCT02151253
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
A Phase 2/3 study testing Armodafinil in people with Nocturia and Daytime Sleepiness, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nocturia, Daytime Sleepiness
- What is being tested?
- Armodafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
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
- Being tested
- Armodafinil, Placebo
- Keywords
- Nocturia, Daytime sleepiness
- Medical subject headings
- Nocturia, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmodafinilDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Armodafinil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4 of each phase
Secondary outcomes (4)
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
Scale consists of a 7 point likert rating scale where the anchors were 1= "normal"; 2= "borderline sleepiness"; 3= "mild sleepiness"; 4= "moderate sleepiness"; 5= "marked sleepiness"; 6= "severe sleepiness"; and 7= "among the most extremely sleepy individuals"
Measured: week 4, of each phase
Mean Number of Naps/Day
measurements are for the preceding week
Measured: week 4 of each phase.
Mean Number of Minutes Napped Per Day Based on Sleep Diary
measurements are for the preceding week
Measured: week 4 of each phase.
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Measured: week 4 of each phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startMay 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Krystal, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151253
- Sponsor's protocol ID
- Pro00028116
- Status last verified
- Mar 2017
- First submitted
- 28 May 2014
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
- ClinicalTrials.gov ID
- NCT02151253
- Acronym / sponsor ID
- Pro00028116
- Conditions
- Nocturia, Daytime Sleepiness
- Keywords
- Nocturia, Daytime sleepiness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armodafinil First, Then Placebo | Experimental | Drug: Armodafinil, Drug: PlaceboDuring 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. |
| Placebo First, Then Armodafinil | Placebo comparator | Drug: Armodafinil, Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArmodafinilArmodafinil 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. | Drug | Armodafinil First, Then Placebo, Placebo First, Then Armodafinil |
| PlaceboSubject 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. | Drug | Armodafinil First, Then Placebo, Placebo First, Then Armodafinil |
Primary outcome
Change From Baseline in Epworth Sleepiness Scale [ESS]
Time frame: Baseline, Week 4 of each phase
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.
4 secondary outcomes
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
Time frame: week 4, of each phase
Mean Number of Naps/Day
Time frame: week 4 of each phase.
Mean Number of Minutes Napped Per Day Based on Sleep Diary
Time frame: week 4 of each phase.
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Time frame: week 4 of each phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Krystal, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Armodafinil in people with Nocturia and Daytime Sleepiness, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Epworth Sleepiness Scale [ESS] (time frame: Baseline, Week 4 of each phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.