Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391755
Status:
TERMINATED
Last Update Posted:
2012-02-10
First Post:
2006-10-22
Brief Title:
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Sponsor:
Charlottesville Neuroscience
Organization:
Charlottesville Neuroscience
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Failure to recruit necessary number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To study the effect of Rozerem a high affinity MT1 and MT2 low affinity 5-HT2B receptor agonist used for insomnia as a migraine prophylactic agent
Detailed Description:
In a recent large study of migraineurs over half reported difficulties with sleep initiation or maintenance Those who had shorter average sleep times reported more severe headaches Poor sleep has been associated with increased frequency and severity of migraines The improvement of migraine frequency with improved sleep hygiene has been documented
PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches Polysomnography has shown specific headache types to occur in specific sleep stages
Melatonin has been effective primarily in headache due to delayed sleep phase syndrome Recent studies support the efficacy of melatonin in treating migraine The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication If effective the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep
Hypothesis Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin
PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches Polysomnography has shown specific headache types to occur in specific sleep stages
Melatonin has been effective primarily in headache due to delayed sleep phase syndrome Recent studies support the efficacy of melatonin in treating migraine The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication If effective the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep
Hypothesis Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None