Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01329562
Status:
COMPLETED
Last Update Posted:
2014-04-09
First Post:
2011-03-17
Brief Title:
CGRP Estrogen Cortisol VIP α-Amylase PGE2 PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet
Sponsor:
Cady Roger MD
Organization:
Cady Roger MD
Study Overview
Official Title:
Evaluation of CGRP Estrogen Cortisol VIP α-Amylase PGE2 PGI2 and ß-Endorphin Levels in Saliva of Menstrual Migraine Patients Before and After Treatment With Treximet
Status:
COMPLETED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to 1 evaluate pain-free efficacy of Treximet following treatment of menstrual migraine 2 investigate levels of Calcitonin gene-related peptide CGRP estrogen cortisol vasoactive intestinal peptide VIP alpha a-amylase Prostaglandin E2 PGE2 Prostaglandin I2 PGI2 and beta ß-endorphin in saliva before and after Treximet 3 evaluate efficacy of Treximet to return to baseline levels following treatment and 4 correlate estrogen in saliva vs urinary estradiol at mid-luteal onset of menstrually-related migraine and after successful treatment with Treximet
Detailed Description:
This double-blind multi-site study will be conducted to enroll 40 evaluable participants All subjects will be medically stable at enrollment and be on a stabilized dosage of daily medications
At Visit 1 Baseline following Informed Consent a physical and neurological exam baseline electrocardiogram ECG and vital signs will be completed A urine pregnancy test will be collected by all subjects of childbearing potential Routine labs electrolyte panel with creatinine alanine aminotransferase ALT aspartate aminotransferase AST a luteinizing hormone LH lab for menstrual cycle staging and a baseline saliva sample for CGRP estrogen cortisol VIP a-amylase PGI2 PGE2 and β-endorphin analysis will be collected Subjects should be headache-free at Visit 1 A medical headache and medication history will be collected on all subjects and eligible subjects will be randomized 11 to Group A or Group B Group A will receive Treximet sumatriptan succinate 85 milligrams mg and naproxen sodium 500 mg 1 tablet Group B will be provided 1 matching placebo tablet Subjects will be instructed to not start study medication until notified by study staff that lab results were normal and they are eligible to proceed Subjects will be instructed to treat as early as possible following the onset of a typical menstrual headache Groups A and B will be provided with Treximet 1 tablet for rescue between 2 and 24 hours for persistent or recurring headache Subjects will receive a Diary and instructions on Digital Versatile Disc DVD regarding documentation Migraine associated symptoms ie nausea vomiting light sensitivity or sound sensitivity will be collected as well as sleeplessness difficulty thinking other bodily pain and menstrual associated symptoms to include intensity of menstrual cramps
Subjects will be given kits with written instructions for collection of urine and saliva samples and additional saliva instructions on DVD All subjects will be given LH testing kits to define the time of ovulation Diary documentation begins at the time of ovulation They will collect baseline saliva and first morning urine samples during the mid-luteal time period for two consecutive days which is defined as 4-7 days after the LH surge Subjects will also be instructed to begin collection of saliva 48 hours prior to the start of menses at 800 am 200 pm and 800 pm for two days or until menstrual migraine occurs They also will collect a first morning urine sample on the two mornings prior to menses At the point of headache onset subjects will be instructed to collect saliva at onset of pain time of treatment 2 and 24 hours following treatment at pain free 2 hours after pain free and 24 hours after pain free Subjects will also be instructed to collect a urine specimen when they are pain free following treatment with study medication Subjects will document migraine associated symptoms menstrual associated symptoms and recurrence symptoms at all saliva collection time points in the provided Diary per instruction
Subjects should be instructed to phone the study coordinator at the end of the menstrual cycle to return for Visit 2 within 7 days
_________________________
At Visit 2 Review Diaries will be reviewed and frozen saliva and urine samples will be returned to the clinic Subjects must meet the following criteria for urine and saliva analysis
Diary review indicates that headache would have if left untreated at least one symptom of migraine nausea vomiting phonophobia or photophobia And
Headache was associated with the onset of menses
And
Saliva and urine samples are returned to the clinic
Medical and medication history will be updated and adverse events collected A urine pregnancy test will be collected by all subjects of childbearing potential Drug accountability and compliance will be assessed
At Visit 1 Baseline following Informed Consent a physical and neurological exam baseline electrocardiogram ECG and vital signs will be completed A urine pregnancy test will be collected by all subjects of childbearing potential Routine labs electrolyte panel with creatinine alanine aminotransferase ALT aspartate aminotransferase AST a luteinizing hormone LH lab for menstrual cycle staging and a baseline saliva sample for CGRP estrogen cortisol VIP a-amylase PGI2 PGE2 and β-endorphin analysis will be collected Subjects should be headache-free at Visit 1 A medical headache and medication history will be collected on all subjects and eligible subjects will be randomized 11 to Group A or Group B Group A will receive Treximet sumatriptan succinate 85 milligrams mg and naproxen sodium 500 mg 1 tablet Group B will be provided 1 matching placebo tablet Subjects will be instructed to not start study medication until notified by study staff that lab results were normal and they are eligible to proceed Subjects will be instructed to treat as early as possible following the onset of a typical menstrual headache Groups A and B will be provided with Treximet 1 tablet for rescue between 2 and 24 hours for persistent or recurring headache Subjects will receive a Diary and instructions on Digital Versatile Disc DVD regarding documentation Migraine associated symptoms ie nausea vomiting light sensitivity or sound sensitivity will be collected as well as sleeplessness difficulty thinking other bodily pain and menstrual associated symptoms to include intensity of menstrual cramps
Subjects will be given kits with written instructions for collection of urine and saliva samples and additional saliva instructions on DVD All subjects will be given LH testing kits to define the time of ovulation Diary documentation begins at the time of ovulation They will collect baseline saliva and first morning urine samples during the mid-luteal time period for two consecutive days which is defined as 4-7 days after the LH surge Subjects will also be instructed to begin collection of saliva 48 hours prior to the start of menses at 800 am 200 pm and 800 pm for two days or until menstrual migraine occurs They also will collect a first morning urine sample on the two mornings prior to menses At the point of headache onset subjects will be instructed to collect saliva at onset of pain time of treatment 2 and 24 hours following treatment at pain free 2 hours after pain free and 24 hours after pain free Subjects will also be instructed to collect a urine specimen when they are pain free following treatment with study medication Subjects will document migraine associated symptoms menstrual associated symptoms and recurrence symptoms at all saliva collection time points in the provided Diary per instruction
Subjects should be instructed to phone the study coordinator at the end of the menstrual cycle to return for Visit 2 within 7 days
_________________________
At Visit 2 Review Diaries will be reviewed and frozen saliva and urine samples will be returned to the clinic Subjects must meet the following criteria for urine and saliva analysis
Diary review indicates that headache would have if left untreated at least one symptom of migraine nausea vomiting phonophobia or photophobia And
Headache was associated with the onset of menses
And
Saliva and urine samples are returned to the clinic
Medical and medication history will be updated and adverse events collected A urine pregnancy test will be collected by all subjects of childbearing potential Drug accountability and compliance will be assessed
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