- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02151253
Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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. |
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.
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.
|
Placebo-jämförare: 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. |
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change From Baseline in Epworth Sleepiness Scale [ESS]
Tidsram: 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.
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Baseline, Week 4 of each phase
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
Tidsram: week 4, of each phase
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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"
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week 4, of each phase
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Mean Number of Naps/Day
Tidsram: week 4 of each phase.
|
measurements are for the preceding week
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week 4 of each phase.
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Mean Number of Minutes Napped Per Day Based on Sleep Diary
Tidsram: week 4 of each phase.
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measurements are for the preceding week
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week 4 of each phase.
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Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
Tidsram: week 4 of each phase.
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Nocturic Events is defined as an episode of urination preceded and followed by sleep.
Measurements are for the preceding week
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week 4 of each phase.
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Andrew Krystal, MD, Duke University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Sjukdomar i nervsystemet
- Sömnstörningar, inneboende
- Dyssomni
- Vakna sömnstörningar
- Symtom i de nedre urinvägarna
- Urologiska manifestationer
- Störningar av överdriven somnolens
- Sömnighet
- Nocturia
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Cytokrom P-450 enzyminducerare
- Cytokrom P-450 CYP3A-inducerare
- Centrala nervsystemets stimulantia
- Vakenhetsfrämjande medel
- Modafinil
Andra studie-ID-nummer
- Pro00028116
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