Trial Outcomes & Findings for Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia (NCT NCT02151253)
NCT ID: NCT02151253
Last Updated: 2017-03-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
81 participants
Primary outcome timeframe
Baseline, Week 4 of each phase
Results posted on
2017-03-24
Participant Flow
Eighty-one individuals signed consent and were screened for entry into this study. Thirty of these subjects met the inclusion/exclusion criteria but only 28 subjects were randomized to the study. (2 subjects withdrew consent prior to randomization).
Participant milestones
| Measure |
Armodafinil First, Then Placebo
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.
|
Placebo First, Then Armodafinil
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
15
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=28 Participants
|
|---|---|
|
Age, Customized
Between 18 and 90
|
54.5 years
STANDARD_DEVIATION 14.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
17 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
9 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4 of each phaseEpworth 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.
Outcome measures
| Measure |
Armodafinil
n=28 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Change From Baseline in Epworth Sleepiness Scale [ESS]
|
9.03 units on a scale
Standard Deviation 5.18
|
9.73 units on a scale
Standard Deviation 4.43
|
SECONDARY outcome
Timeframe: week 4, of each phaseScale 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"
Outcome measures
| Measure |
Armodafinil
n=28 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
|
2.58 units on a scale
Standard Deviation 1.03
|
3.12 units on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: week 4 of each phase.measurements are for the preceding week
Outcome measures
| Measure |
Armodafinil
n=28 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Mean Number of Naps/Day
|
0.48 naps per day
Standard Deviation 0.71
|
0.73 naps per day
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: week 4 of each phase.measurements are for the preceding week
Outcome measures
| Measure |
Armodafinil
n=28 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Mean Number of Minutes Napped Per Day Based on Sleep Diary
|
38.9 minutes napped per day
Standard Deviation 65.1
|
40.0 minutes napped per day
Standard Deviation 61.3
|
SECONDARY outcome
Timeframe: week 4 of each phase.Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week
Outcome measures
| Measure |
Armodafinil
n=28 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
|
1.6 Nocturic Events
Standard Deviation 1.1
|
1.89 Nocturic Events
Standard Deviation 1.1
|
Adverse Events
Armodafinil
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Armodafinil
n=28 participants at risk
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.
|
Placebo
n=28 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
14.3%
4/28
|
14.3%
4/28
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Infection
|
3.6%
1/28
|
0.00%
0/28
|
|
Psychiatric disorders
Anxiety/Jitteriness
|
14.3%
4/28
|
10.7%
3/28
|
|
Psychiatric disorders
insomnia
|
3.6%
1/28
|
0.00%
0/28
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28
|
3.6%
1/28
|
|
General disorders
Dizziness
|
0.00%
0/28
|
3.6%
1/28
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/28
|
3.6%
1/28
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28
|
3.6%
1/28
|
Additional Information
Andrew D. Krystal, MD, MS
Duke University Health System
Phone: 919-971-4355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place