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Health Condition(s) or Problem
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Sleep Initiation and Maintenance Disorders; Insomnia
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Lay Summary
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The purpose of the study is to assess efficacy and safety of eplivanserin in the population
of patients complaining of sleep maintenance insomnia. The patients suffering from that
condition frequently wake up during the night, their sleep is nonrestorative and they suffer
from a significant distress or impairment in their daily activities consecutive to insomnia.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Out patients
- Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria
- Based on patient's information, the patient has spent at least 6.5 hours and not more
than 9.0 hours, in bed, each night, over the preceding two weeks.
- Based on patient's information, the patient must complain of at least one hour of
wakefulness after sleep onset for at least 3 nights per week over the preceding month
- Patient must report impact daytime functioning associated with sleep maintenance
insomnia as measured by question 3 of Insomnia Severity Index at screening visit and
randomization visit.
Exclusion Criteria:
- Females who are lactating or pregnant
- Woman of childbearing potential with a positive serum beta human chorionic
gonadotropin pregnancy test at screening and not using an acceptable form of
contraception
- Patients presenting with acute or chronic pain resulting in insomnia
- Patients with history of epilepsy or seizures
- Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising
more than 5 glasses/day
- Evidence of any clinically significant, severe, or unstable acute or chronically
progressive medical or surgical disorder which may affect patient safety
- BMI >32
- Acute or chronic pain resulting in insomnia
- Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental
retardation, or dementia
- Clinically significant and abnormal EKG (QTc interval >500 msec)
- Positive for hepatitis B or C
- Serious head injury or stroke within 1 year
- Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or
alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
- Participation in another trial within two month before the screening visit
- Use of any substance with psychotropic effects or properties known to affect
sleep/wake
- Unable to complete the study questionnaires
- Night shift workers, and individuals who nap 3 or more times per week over the
preceding month
- History of:
- Primary hypersomnia
- Narcolepsy
- Breathing-related sleep disorder (such as sleep apnea)
- Circadian rhythm sleep disorder
- Parasomnia (somnambulism)
- Dyssomnia (such as periodic leg movements)
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Who cannot enter the trial
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Inclusion Criteria:
- Out patients
- Each patient must have primary insomnia in accordance with DSM-IV-TR-Axis I criteria
- Based on patient's information, the patient has spent at least 6.5 hours and not more
than 9.0 hours, in bed, each night, over the preceding two weeks.
- Based on patient's information, the patient must complain of at least one hour of
wakefulness after sleep onset for at least 3 nights per week over the preceding month
- Patient must report impact daytime functioning associated with sleep maintenance
insomnia as measured by question 3 of Insomnia Severity Index at screening visit and
randomization visit.
Exclusion Criteria:
- Females who are lactating or pregnant
- Woman of childbearing potential with a positive serum beta human chorionic
gonadotropin pregnancy test at screening and not using an acceptable form of
contraception
- Patients presenting with acute or chronic pain resulting in insomnia
- Patients with history of epilepsy or seizures
- Consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising
more than 5 glasses/day
- Evidence of any clinically significant, severe, or unstable acute or chronically
progressive medical or surgical disorder which may affect patient safety
- BMI >32
- Acute or chronic pain resulting in insomnia
- Patients with current psychiatric disorders according to DSM-IV-TR criteria, mental
retardation, or dementia
- Clinically significant and abnormal EKG (QTc interval >500 msec)
- Positive for hepatitis B or C
- Serious head injury or stroke within 1 year
- Use of OTC medications such as valerian root, kava, melatonin, St. John's Wort, or
alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives
- Participation in another trial within two month before the screening visit
- Use of any substance with psychotropic effects or properties known to affect
sleep/wake
- Unable to complete the study questionnaires
- Night shift workers, and individuals who nap 3 or more times per week over the
preceding month
- History of:
- Primary hypersomnia
- Narcolepsy
- Breathing-related sleep disorder (such as sleep apnea)
- Circadian rhythm sleep disorder
- Parasomnia (somnambulism)
- Dyssomnia (such as periodic leg movements)
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What will happen
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Drug; eplivanserin (SR46349); oral administration; 1; Drug; placebo; oral administration; 2
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Primary aim
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Change from baseline of the mean pr-WASO (wake time after sleep onset using patient's sleep questionnaire)
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Secondary Aim
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Change from baseline of the mean of the FOSQ items 1 and 2 (concentration/memory); at week 12; No; Change from baseline of the mean of the FOSQ items 4 and 10 (hobby/work); at week 12; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Completed
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Nation
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England
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Location
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Guildford
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