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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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™.
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 1:1 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 8:00 am, 2:00 pm, and 8:00 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treximet | Active Comparator | Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. |
|
| Placebo | Placebo Comparator | Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treximet | Drug | Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Recurrence | Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine. 0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe. | From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment. |
| Time to Pain Free | Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms. 0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe. | From onset of 1 menstrual migraine headache until pain free. |
| Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment | Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. | From Baseline until 2 hours post treatment of 1 menstrual migraine headache |
| CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment | CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | From Baseline until 2 hours post treatment for 1 menstrual migraine headache |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Recurrence Responders vs Non-Responders | Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders. 0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe *A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. |
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Inclusion Criteria:
Subject
is female between the ages of 18-45 and, if of child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and agrees to one of the following:
is formally diagnosed with International Classification of Headache Disorders (ICHD) menstrual migraine
has regular and predictable monthly menstrual cycles within a range of 22-32 days for the past 3 cycles.
has fewer than 15 headache days per month in past 3 months
has headache that, if left untreated, would have at least 1 symptom of migraine (nausea, vomiting, photophobia, or phonophobia) or respond to a triptan or ergotamine-containing medication with at least 50% of headaches
has a history of reliably predicting menstrual migraine headache onset at least 70% of the time
is medically stable as determined by the Investigator
if taking any concomitant medications, is on a stabilized dosage at the discretion of the investigator
is able to understand and communicate intelligibly with the study observer
is able to take oral medication, adhere to the medication regimens and perform study procedures
is able to read and comprehend written instructions and be willing to complete all procedures and assessments required by this protocol
is able to demonstrate the willingness to participate by signing and understanding an informed consent after full explanation of the study
Exclusion Criteria:
Subject
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| Name | Affiliation | Role |
|---|---|---|
| Roger K Cady, MD | Clinvest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinvest | Springfield | Missouri | 65807 | United States | ||
| University Internal Medicine Associates, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16618254 | Background | Martin VT, Behbehani M. Ovarian hormones and migraine headache: understanding mechanisms and pathogenesis--part 2. Headache. 2006 Mar;46(3):365-86. doi: 10.1111/j.1526-4610.2006.00370.x. | |
| 16412160 | Background | Martin VT, Wernke S, Mandell K, Ramadan N, Kao L, Bean J, Liu J, Zoma W, Rebar R. Symptoms of premenstrual syndrome and their association with migraine headache. Headache. 2006 Jan;46(1):125-37. doi: 10.1111/j.1526-4610.2006.00306.x. |
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Subjects were enrolled and randomized at Visit 1. There were no significant events between enrollment and assignment.
Subjects between the ages of 18 and 45 were recruited from two investigative sites. Subjects were enrolled from May 9,2011 through March 29, 2012. Last patient out June 5,2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Placebo : A placebo tablet matching Treximet for oral administration. |
| FG001 | Treximet | Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Placebo : A placebo tablet matching Treximet for oral administration. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Migraine Recurrence | Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine. 0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe. | Posted | Number | participants | From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Placebo : A placebo tablet matching Treximet for oral administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dull Stomach Ache | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Cady | Clinvest/A Division of Banyan Group Inc. | 417-890-7888 | jtarrasch@clinvest.com |
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| ID | Term |
|---|---|
| C000611385 | sumatriptan-naproxen |
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | A placebo tablet matching Treximet for oral administration. |
|
| α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment |
α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. |
| From Baseline until 2 hours post treatment for 1 menstrual migraine headache |
| Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free. | VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache. * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. | From baseline to 24 hours post headache gone for 1 menstrual migraine headache. |
| CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free. | CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache. * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | From baseline to 24 hours post headache gone for 1 menstrual migraine headache |
| α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free. | α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | From baseline to 24 hours post headache gone for 1 menstrual migraine headache |
| Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free. | Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache *Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point. | From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free |
| From the onset of 1 menstrual migraine until 24 hours post treatment. |
| Time to Pain-Free in Responders vs Non-Responders | Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine. 0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe. *A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From the onset of 1 menstrual migraine headache until pain-free. |
| Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders | VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. ***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache. |
| CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders | CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. **A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache. |
| α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders | α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*. *A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From Baseline until 2 hours post treatment of 1 menstrual migraine headache. |
| Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders | VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. ***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days |
| CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders | CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. **A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From Baseline to 24 hours post headache gone for 1 menstrual migraine. |
| α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders | α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. **A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From Baseline from 24 hours post migraine gone for 1 menstrual migraine. |
| Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders | Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**. *Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point. ***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | From mid luteal phase and for the duration of 1 menstrual migraine until headache free. |
| Cincinnati |
| Ohio |
| 45267-0535 |
| United States |
| 11888029 | Background | Cady R, Dodick DW. Diagnosis and treatment of migraine. Mayo Clin Proc. 2002 Mar;77(3):255-61. doi: 10.4065/77.3.255. |
| 16927957 | Background | Durham PL. Calcitonin gene-related peptide (CGRP) and migraine. Headache. 2006 Jun;46 Suppl 1(Suppl 1):S3-8. doi: 10.1111/j.1526-4610.2006.00483.x. |
| 16123089 | Background | Nappi RE, Sances G, Brundu B, De Taddei S, Sommacal A, Ghiotto N, Polatti F, Nappi G. Estradiol supplementation modulates neuroendocrine response to M-chlorophenylpiperazine in menstrual status migrainosus triggered by oral contraception-free interval. Hum Reprod. 2005 Dec;20(12):3423-8. doi: 10.1093/humrep/dei260. Epub 2005 Aug 25. |
| 16412148 | Background | Bellamy JL, Cady RK, Durham PL. Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients. Headache. 2006 Jan;46(1):24-33. doi: 10.1111/j.1526-4610.2006.00294.x. |
| Subject withdrew due to personal issues. |
|
| Physician Decision |
|
| BG001 | Treximet | Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Treximet |
Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. |
|
|
| Primary | Time to Pain Free | Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms. 0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe. | In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated. | Posted | Mean | Standard Deviation | hours | From onset of 1 menstrual migraine headache until pain free. |
|
|
|
| Primary | Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment | Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. | In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pg/mL | From Baseline until 2 hours post treatment of 1 menstrual migraine headache |
|
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|
| Primary | CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment | CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pmol/mg | From Baseline until 2 hours post treatment for 1 menstrual migraine headache |
|
|
|
| Primary | α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment | α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | U/L | From Baseline until 2 hours post treatment for 1 menstrual migraine headache |
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|
| Secondary | Migraine Recurrence Responders vs Non-Responders | Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders. 0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe *A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Posted | Number | participants | From the onset of 1 menstrual migraine until 24 hours post treatment. |
|
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|
| Secondary | Time to Pain-Free in Responders vs Non-Responders | Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine. 0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe. *A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Posted | Mean | Standard Deviation | hours | From the onset of 1 menstrual migraine headache until pain-free. |
|
|
|
| Secondary | Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders | VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. ***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pg/mL | From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache. |
|
|
|
| Secondary | CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders | CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. **A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pmol/mg | From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache. |
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| Secondary | α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders | α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*. *A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | U/L | From Baseline until 2 hours post treatment of 1 menstrual migraine headache. |
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| Primary | Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free. | VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache. * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. | In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. | Posted | Mean | Standard Deviation | pg/mL | From baseline to 24 hours post headache gone for 1 menstrual migraine headache. |
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| Primary | CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free. | CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache. * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. | Posted | Mean | Standard Deviation | pmol/mg | From baseline to 24 hours post headache gone for 1 menstrual migraine headache |
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| Primary | α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free. | α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. | In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. | Posted | Mean | Standard Deviation | U/L | From baseline to 24 hours post headache gone for 1 menstrual migraine headache |
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| Primary | Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free. | Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache *Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pg/mL | From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free |
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| Secondary | Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders | VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually. **β-endorphin levels were not assayed due to limitations on saliva sample volumes. ***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pg/mL | From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days |
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| Secondary | CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders | CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. **A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pmol/mg | From Baseline to 24 hours post headache gone for 1 menstrual migraine. |
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| Secondary | α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders | α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**. *This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. **A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | U/L | From Baseline from 24 hours post migraine gone for 1 menstrual migraine. |
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| Secondary | Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders | Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**. *Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point. ***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria. | Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors. | Posted | Mean | Standard Deviation | pg/mL | From mid luteal phase and for the duration of 1 menstrual migraine until headache free. |
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| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Treximet | Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain. All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset. Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. | 0 | 21 | 7 | 21 |
| Left Side Jaw Pain | Musculoskeletal and connective tissue disorders |
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| Dry Mouth | General disorders |
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| Feeling of Upper Body Heaviness | General disorders |
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| Dizziness | General disorders |
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| Drowsiness | General disorders |
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| Right Leg Cramping | Musculoskeletal and connective tissue disorders |
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| Shakiness | Nervous system disorders |
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| Worsening Headache | Nervous system disorders |
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| Right Foot Pain | Musculoskeletal and connective tissue disorders | Post bunionectomy |
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| Chest Pain | Cardiac disorders |
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| Head Pressure | Nervous system disorders |
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| Neck Pain | Musculoskeletal and connective tissue disorders |
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| Shoulder Pain | Musculoskeletal and connective tissue disorders |
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| Flushing of Neck | Vascular disorders |
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| Arms Felt Warm | Vascular disorders |
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| Flushing of Face | Vascular disorders |
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| Jaw Tightness | Musculoskeletal and connective tissue disorders |
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| Chest Tightness | Musculoskeletal and connective tissue disorders |
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| Abnormal Alanine Aminotransferase (ALT) | Hepatobiliary disorders |
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Not provided
Not provided
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| VIP 2 Hours Post Treatment (n=9, 13) |
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| PGE2 Baseline (n=10, 14) |
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| PGE2 Migraine Onset (n=10, 13) |
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| PGE2 2 Hours Post Treatment (n=9, 14) |
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| Cortisol Baseline (n=10, 13) |
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| Cortisol Migraine Onset (n=8, 13) |
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| Cortisol 2 Hours Post Treatment (n=8, 10) |
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| PGI2 Baseline (n=10, 14) |
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| PGI2 Migraine Onset (n=10, 13) |
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| PGI2 2 Hours Post Treatment (n=9, 14) |
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| Estradiol Baseline (n=10, 13) |
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| Estradiol Migraine Onset (n=9, 13) |
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| Estradiol 2 Hours Post Treatment (n=9,14) |
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| CGRP 2 Hours Post Treatment (n=9, 14) |
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| α-Amylase 2 Hours Post Treatment (n=9, 14) |
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| VIP 2 Hours Post Treatment (n=9,7,6,) |
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| PGE2 Baseline (n=10,7,7) |
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| PGE2 Migraine Onset (n=10,7,6) |
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| PGE2 2 Hours Post Treatment (n=9,7,7) |
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| Cortisol Baseline (n=10,6,7) |
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| Cortisol Migraine Onset (n=8,7,6) |
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| Cortisol 2 Hours Post Treatment (n=8,6,4) |
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| PGI2 Baseline (n=10,7,7) |
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| PGI2 Migraine Onset (n=10,7,6) |
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| PGI2 2 Hours Post Treatment (n=9,7,7) |
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| Estradiol Baseline (n=9,7,6) |
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| Estradiol Migraine Onset (n=8,7,6) |
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| Estradiol 2 Hours Post Treatment (n=8,7,7) |
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| CGRP 2 Hours Post Treatment (n=9,7,7) |
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| α-Amylase 2 Hours Post Treatment (n=9,7,7) |
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| VIP 24 Hours Migraine Headache Free (n=10,7,6) |
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| PGE2 Migraine Onset (n=10,7,6) |
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| PGE2 Migraine Headache Free (n=10,4,6,) |
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| PGE2 24 Hours Migraine Headache Free (n=10,7,7) |
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| Cortisol Migraine Onset (n=8,7,6) |
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| Cortisol Migraine Headache Free (n=10,3,6) |
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| Cortisol 24 Hours Migraine Headache Free(n=10,6,6) |
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| PGI2 Migraine Onset (n=10,7,6) |
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| PGI2 Migraine Headache Free (n=10,4,6) |
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| PGI2 24 Hours Migraine Headache Free (n=10,7,7) |
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| Estradiol Migraine Onset (n=9,7,6) |
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| Estradiol Migraine Headache Free (n=9,4,5,) |
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| Estradiol 24 Hours Migraine Headache Free(n=6,7,5) |
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| CGRP 24 Hours Migraine Headache Free (n=9,7,7) |
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| α-Amylase 24 Hours Migraine Headache Free(n=10,7,7 |
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| Urine Pre-Cycle Day 3 (n=8, 6) |
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| Urine Pre-Cycle Day 4 (n=9, 10) |
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| Urine Migraine Headache Free (n=11, 13 |
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| Saliva Pre-Cycle Day 1 (n=1, 4) |
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| Saliva Pre-Cycle Day 2 (n=2, 6) |
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| Saliva Pre-Cycle Day 3 (n=8, 10) |
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| Saliva Pre-Cycle Day 4 (n=6, 9) |
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| Saliva Migraine Headache Free (n=8, 6) |
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| VIP 24 Hours Migraine Headache Free (n=10,7,5) |
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| PGE2 Migraine Onset (n=10,7,6) |
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| PGE2 Migraine Headache Free (n=10,4,6) |
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| PGE2 24 Hours Migraine Headache Free (n=10,7,7) |
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| Cortisol Migraine Onset (n=8,7,6) |
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| Cortisol Migraine Headache Free (n=10,3,5) |
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| Cortisol 24 Hours Migraine Headache Free(n=10,6,6) |
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| PGI2 Migraine Onset (n=10,7,6) |
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| PGI2 Migraine Headache Free (n=10,4,6) |
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| PGI2 24 Hours Migraine Headache Free (n=10,7,7) |
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| Estradiol Migraine Onset (n=9,7,6) |
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| Estradiol Migraine Headache Free (n=9,5,4) |
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| Estradiol 24 Hours Migraine Headache Free(n=6,7,6) |
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| CGRP 24 Hours Migraine Headache Free (n=9,7,7) |
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| α-amylase 24 Hours Migraine Headache Free(n=10,4,6 |
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| Urine Pre-Cycle Day 3 (n=8,2,5) |
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| Urine Pre-Cycle Day 4 (n=9,5,5) |
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| Urine Migraine Headache Free (n=10,7,7) |
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| Saliva Pre-Cycle Day 1 (n=1,0,4) |
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| Saliva Pre-Cycle Day 2 (n=2,2,4) |
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| Saliva Pre-Cycle Day 3 (n=8,4,7) |
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| Saliva Pre-Cycle Day 4 (n=8,5,4) |
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| Saliva Migraine Headache Free (n=8,3,4) |
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