Trial Outcomes & Findings for CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet (NCT NCT01329562)
NCT ID: NCT01329562
Last Updated: 2014-04-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.
Results posted on
2014-04-09
Participant Flow
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.
Subjects were enrolled and randomized at Visit 1. There were no significant events between enrollment and assignment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
|
Overall Study
COMPLETED
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Subject withdrew due to personal issues.
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Menstrual Migraine Before and After Treximet
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
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.
|
Treximet
n=21 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
34.35 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
36.71 years
STANDARD_DEVIATION 6.50 • n=7 Participants
|
35.56 years
STANDARD_DEVIATION 7.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Migraine Recurrence
|
0 participants
|
2 participants
|
—
|
PRIMARY outcome
Timeframe: From onset of 1 menstrual migraine headache until pain free.Population: In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Time to Pain Free
|
7.64 hours
Standard Deviation 4.06
|
3.90 hours
Standard Deviation 3.92
|
—
|
PRIMARY outcome
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headachePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
VIP Baseline (n=10, 14)
|
763.6 pg/mL
Standard Deviation 341.01
|
1149.5 pg/mL
Standard Deviation 532.07
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
VIP Migraine Onset (n=10, 13)
|
1052.8 pg/mL
Standard Deviation 490.57
|
1111.31 pg/mL
Standard Deviation 560.39
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
VIP 2 Hours Post Treatment (n=9, 13)
|
1130.44 pg/mL
Standard Deviation 600.29
|
933.77 pg/mL
Standard Deviation 643.38
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
PGE2 Baseline (n=10, 14)
|
9.25 pg/mL
Standard Deviation 7.97
|
12.65 pg/mL
Standard Deviation 11.33
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
PGE2 Migraine Onset (n=10, 13)
|
7.56 pg/mL
Standard Deviation 2.61
|
13.02 pg/mL
Standard Deviation 7.55
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
PGE2 2 Hours Post Treatment (n=9, 14)
|
8.29 pg/mL
Standard Deviation 4.43
|
7.99 pg/mL
Standard Deviation 4.37
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Cortisol Baseline (n=10, 13)
|
1064.14 pg/mL
Standard Deviation 970.57
|
1040.49 pg/mL
Standard Deviation 1292.8
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Cortisol Migraine Onset (n=8, 13)
|
1084.85 pg/mL
Standard Deviation 758.46
|
1209.34 pg/mL
Standard Deviation 1795.19
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Cortisol 2 Hours Post Treatment (n=8, 10)
|
2011.45 pg/mL
Standard Deviation 2259.76
|
418.48 pg/mL
Standard Deviation 211.93
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
PGI2 Baseline (n=10, 14)
|
109.51 pg/mL
Standard Deviation 62.90
|
160.27 pg/mL
Standard Deviation 100.22
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
PGI2 Migraine Onset (n=10, 13)
|
108.23 pg/mL
Standard Deviation 61.25
|
158.29 pg/mL
Standard Deviation 76.74
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
PGI2 2 Hours Post Treatment (n=9, 14)
|
97.58 pg/mL
Standard Deviation 54.70
|
201.60 pg/mL
Standard Deviation 115.16
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Estradiol Baseline (n=10, 13)
|
63.37 pg/mL
Standard Deviation 42.24
|
62.61 pg/mL
Standard Deviation 78.16
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Estradiol Migraine Onset (n=9, 13)
|
41.68 pg/mL
Standard Deviation 30.43
|
43.93 pg/mL
Standard Deviation 36.85
|
—
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
Estradiol 2 Hours Post Treatment (n=9,14)
|
54.07 pg/mL
Standard Deviation 36.45
|
41.66 pg/mL
Standard Deviation 22.19
|
—
|
PRIMARY outcome
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headachePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
CGRP Baseline (n=10, 14)
|
18.55 pmol/mg
Standard Deviation 16.98
|
15.03 pmol/mg
Standard Deviation 11.73
|
—
|
|
CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
CGRP Migraine Onset (n=10, 13)
|
22.28 pmol/mg
Standard Deviation 14.45
|
27.82 pmol/mg
Standard Deviation 36.66
|
—
|
|
CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
CGRP 2 Hours Post Treatment (n=9, 14)
|
14.92 pmol/mg
Standard Deviation 11.96
|
21.38 pmol/mg
Standard Deviation 11.45
|
—
|
PRIMARY outcome
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headachePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
α-Amylase Migraine Onset (n=10, 13)
|
100956.70 U/L
Standard Deviation 13551.51
|
98853.32 U/L
Standard Deviation 12958.58
|
—
|
|
α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
α-Amylase 2 Hours Post Treatment (n=9, 14)
|
102449.80 U/L
Standard Deviation 4883.00
|
103594.90 U/L
Standard Deviation 9335.72
|
—
|
|
α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
α-Amylase Baseline (n=10, 14)
|
109280.50 U/L
Standard Deviation 12499.73
|
99626.61 U/L
Standard Deviation 7616.14
|
—
|
PRIMARY outcome
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache.Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Estradiol Migraine Onset (n=9,7,6)
|
37.05 pg/mL
Standard Deviation 31.67
|
43.93 pg/mL
Standard Deviation 36.85
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
VIP Migraine Onset (n=10,7,6)
|
1052.8 pg/mL
Standard Deviation 490.57
|
1111.31 pg/mL
Standard Deviation 560.39
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
VIP Migraine Headache Free (n=9,4,7)
|
964.4 pg/mL
Standard Deviation 711.43
|
949.7 pg/mL
Standard Deviation 536.21
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
VIP 24 Hours Migraine Headache Free (n=10,7,6)
|
1059.9 pg/mL
Standard Deviation 564.42
|
1353.04 pg/mL
Standard Deviation 629.56
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
PGE2 Migraine Onset (n=10,7,6)
|
7.56 pg/mL
Standard Deviation 2.61
|
13.02 pg/mL
Standard Deviation 7.55
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
PGE2 Migraine Headache Free (n=10,4,6,)
|
8.35 pg/mL
Standard Deviation 6.52
|
9.27 pg/mL
Standard Deviation 6.74
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
PGE2 24 Hours Migraine Headache Free (n=10,7,7)
|
10.46 pg/mL
Standard Deviation 11.43
|
13.04 pg/mL
Standard Deviation 12.03
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Cortisol Migraine Onset (n=8,7,6)
|
1084.5 pg/mL
Standard Deviation 7584.6
|
1209.34 pg/mL
Standard Deviation 1795.19
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Cortisol Migraine Headache Free (n=10,3,6)
|
1490.92 pg/mL
Standard Deviation 2232.7
|
1498.92 pg/mL
Standard Deviation 1945.6
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Cortisol 24 Hours Migraine Headache Free(n=10,6,6)
|
1031.16 pg/mL
Standard Deviation 1474.05
|
1271.4 pg/mL
Standard Deviation 1606.11
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
PGI2 Migraine Onset (n=10,7,6)
|
108.23 pg/mL
Standard Deviation 61.25
|
158.29 pg/mL
Standard Deviation 76.74
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
PGI2 Migraine Headache Free (n=10,4,6)
|
115.63 pg/mL
Standard Deviation 78.71
|
167.48 pg/mL
Standard Deviation 94.28
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
PGI2 24 Hours Migraine Headache Free (n=10,7,7)
|
97.69 pg/mL
Standard Deviation 63.84
|
224.58 pg/mL
Standard Deviation 160.51
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Estradiol Migraine Headache Free (n=9,4,5,)
|
48.83 pg/mL
Standard Deviation 48.82
|
39.92 pg/mL
Standard Deviation 45.55
|
—
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
Estradiol 24 Hours Migraine Headache Free(n=6,7,5)
|
21.34 pg/mL
Standard Deviation 26.35
|
56.33 pg/mL
Standard Deviation 53.49
|
—
|
PRIMARY outcome
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headachePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
CGRP Migraine Onset (n=10,7,6)
|
22.28 pmol/mg
Standard Deviation 14.45
|
28.82 pmol/mg
Standard Deviation 36.66
|
—
|
|
CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
CGRP Migraine Headache Free (n=9,4,6)
|
22.55 pmol/mg
Standard Deviation 30.87
|
32.26 pmol/mg
Standard Deviation 34.89
|
—
|
|
CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
CGRP 24 Hours Migraine Headache Free (n=9,7,7)
|
29.37 pmol/mg
Standard Deviation 26.76
|
32.15 pmol/mg
Standard Deviation 27.74
|
—
|
PRIMARY outcome
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headachePopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
α-Amylase Migraine Onset (n=10,7,6)
|
100956.70 U/L
Standard Deviation 13551.51
|
98853.32 U/L
Standard Deviation 12958.58
|
—
|
|
α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
α-Amylase Migraine Headache Free (n=10,4,6)
|
102908.61 U/L
Standard Deviation 11522.83
|
101307.25 U/L
Standard Deviation 8347.11
|
—
|
|
α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
α-Amylase 24 Hours Migraine Headache Free(n=10,7,7
|
100354.00 U/L
Standard Deviation 16608.96
|
102017.80 U/L
Standard Deviation 8825.01
|
—
|
PRIMARY outcome
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache freePopulation: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Treximet
n=14 Participants
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.
|
Treximet Non-Responder
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Saliva Pre-Cycle Day 3 (n=8, 10)
|
46.47 pg/mL
Standard Deviation 34.73
|
73.08 pg/mL
Standard Deviation 58.17
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Urine Pre-Cycle Day 1 (n=3, 6)
|
2442.44 pg/mL
Standard Deviation 545.38
|
3090.92 pg/mL
Standard Deviation 2306.67
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Urine Pre-Cycle Day 2 (n=6, 8)
|
4333.92 pg/mL
Standard Deviation 2982.35
|
2616.64 pg/mL
Standard Deviation 2833.28
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Urine Pre-Cycle Day 3 (n=8, 6)
|
3582.92 pg/mL
Standard Deviation 4121.17
|
5089.63 pg/mL
Standard Deviation 5775.30
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Urine Pre-Cycle Day 4 (n=9, 10)
|
3232.10 pg/mL
Standard Deviation 2941.52
|
3141.51 pg/mL
Standard Deviation 2237.74
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Urine Migraine Headache Free (n=11, 13
|
2398.55 pg/mL
Standard Deviation 1872.88
|
2989.72 pg/mL
Standard Deviation 3823.33
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Saliva Pre-Cycle Day 1 (n=1, 4)
|
41.75 pg/mL
Standard Deviation NA
Only one subject's level was reportable for this single collection time point, therefore; mean and standard deviation could not be calculated with only one reported value.
|
43.33 pg/mL
Standard Deviation 23.19
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Saliva Pre-Cycle Day 2 (n=2, 6)
|
63.45 pg/mL
Standard Deviation 57.60
|
41.87 pg/mL
Standard Deviation 17.73
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Saliva Pre-Cycle Day 4 (n=6, 9)
|
55.86 pg/mL
Standard Deviation 50.17
|
41.72 pg/mL
Standard Deviation 31.69
|
—
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
Saliva Migraine Headache Free (n=8, 6)
|
54.93 pg/mL
Standard Deviation 48.38
|
51.32 pg/mL
Standard Deviation 45.64
|
—
|
SECONDARY outcome
Timeframe: From the onset of 1 menstrual migraine until 24 hours post treatment.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.
Outcome measures
| Measure |
Placebo
n=11 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Migraine Recurrence Responders vs Non-Responders
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From the onset of 1 menstrual migraine headache until pain-free.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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Time to Pain-Free in Responders vs Non-Responders
|
7.64 hours
Standard Deviation 4.06
|
3.13 hours
Standard Deviation 4.05
|
4.68 hours
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.Population: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
PGI2 Migraine Onset (n=10,7,6)
|
108.23 pg/mL
Standard Deviation 61.25
|
134.40 pg/mL
Standard Deviation 71.0
|
186.17 pg/mL
Standard Deviation 79.71
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
VIP Baseline (n=10,7,7)
|
763.6 pg/mL
Standard Deviation 341.01
|
1414.0 pg/mL
Standard Deviation 618.96
|
885.0 pg/mL
Standard Deviation 258.91
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
VIP Migraine Onset (n=10,7,6)
|
1052.8 pg/mL
Standard Deviation 490.57
|
1251.14 pg/mL
Standard Deviation 580.38
|
948.17 pg/mL
Standard Deviation 538.67
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
VIP 2 Hours Post Treatment (n=9,7,6,)
|
1130.44 pg/mL
Standard Deviation 600.29
|
1320.14 pg/mL
Standard Deviation 657.68
|
414.0 pg/mL
Standard Deviation 226.53
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
PGE2 Baseline (n=10,7,7)
|
9.25 pg/mL
Standard Deviation 7.97
|
14.29 pg/mL
Standard Deviation 12.12
|
11.01 pg/mL
Standard Deviation 11.12
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
PGE2 Migraine Onset (n=10,7,6)
|
7.56 pg/mL
Standard Deviation 2.61
|
14.13 pg/mL
Standard Deviation 9.48
|
11.72 pg/mL
Standard Deviation 5.02
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
PGE2 2 Hours Post Treatment (n=9,7,7)
|
8.29 pg/mL
Standard Deviation 4.43
|
6.83 pg/mL
Standard Deviation 4.97
|
9.15 pg/mL
Standard Deviation 3.69
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Cortisol Baseline (n=10,6,7)
|
1064.14 pg/mL
Standard Deviation 970.57
|
790.77 pg/mL
Standard Deviation 633.65
|
1254.53 pg/mL
Standard Deviation 1700.66
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Cortisol Migraine Onset (n=8,7,6)
|
1084.5 pg/mL
Standard Deviation 758.46
|
952.52 pg/mL
Standard Deviation 864.35
|
1508.97 pg/mL
Standard Deviation 2576.41
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Cortisol 2 Hours Post Treatment (n=8,6,4)
|
2011.45 pg/mL
Standard Deviation 2259.76
|
482.32 pg/mL
Standard Deviation 253.59
|
322.72 pg/mL
Standard Deviation 84.78
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
PGI2 Baseline (n=10,7,7)
|
109.51 pg/mL
Standard Deviation 62.90
|
142.99 pg/mL
Standard Deviation 65.71
|
177.54 pg/mL
Standard Deviation 129.41
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
PGI2 2 Hours Post Treatment (n=9,7,7)
|
97.58 pg/mL
Standard Deviation 54.70
|
155.56 pg/mL
Standard Deviation 63.48
|
247.63 pg/mL
Standard Deviation 140.58
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Estradiol Baseline (n=9,7,6)
|
63.37 pg/mL
Standard Deviation 42.24
|
49.60 pg/mL
Standard Deviation 54.34
|
66.68 pg/mL
Standard Deviation 98.50
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Estradiol Migraine Onset (n=8,7,6)
|
37.05 pg/mL
Standard Deviation 31.67
|
44.89 pg/mL
Standard Deviation 41.81
|
42.81 pg/mL
Standard Deviation 34.04
|
|
Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
Estradiol 2 Hours Post Treatment (n=8,7,7)
|
54.07 pg/mL
Standard Deviation 36.45
|
36.64 pg/mL
Standard Deviation 23.20
|
46.68 pg/mL
Standard Deviation 21.67
|
SECONDARY outcome
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.Population: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders
CGRP Baseline (n=10,7,7)
|
18.55 pmol/mg
Standard Deviation 16.98
|
12.27 pmol/mg
Standard Deviation 6.61
|
17.80 pmol/mg
Standard Deviation 15.39
|
|
CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders
CGRP Migraine Onset (n=10,7,6)
|
22.28 pmol/mg
Standard Deviation 14.45
|
22.74 pmol/mg
Standard Deviation 11.94
|
33.76 pmol/mg
Standard Deviation 54.55
|
|
CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders
CGRP 2 Hours Post Treatment (n=9,7,7)
|
14.92 pmol/mg
Standard Deviation 11.96
|
21.08 pmol/mg
Standard Deviation 8.02
|
21.67 pmol/mg
Standard Deviation 14.81
|
SECONDARY outcome
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache.Population: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
α-Amylase Baseline (n=10,7,7)
|
109280.50 U/L
Standard Deviation 12499.73
|
98002.68 U/L
Standard Deviation 6613.71
|
101250.54 U/L
Standard Deviation 8705.42
|
|
α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
α-Amylase Migraine Onset (n=10,7,6)
|
100956.7 U/L
Standard Deviation 13551.51
|
103478.94 U/L
Standard Deviation 10789.63
|
93456.77 U/L
Standard Deviation 14086.68
|
|
α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
α-Amylase 2 Hours Post Treatment (n=9,7,7)
|
102449.88 U/L
Standard Deviation 4883.0
|
103527.5 U/L
Standard Deviation 12084.79
|
103662.4 U/L
Standard Deviation 6540.98
|
SECONDARY outcome
Timeframe: From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 daysPopulation: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Estradiol 24 Hours Migraine Headache Free(n=6,7,6)
|
21.34 pg/mL
Standard Deviation 26.35
|
34.86 pg/mL
Standard Deviation 46.64
|
81.38 pg/mL
Standard Deviation 53.46
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
VIP Migraine Onset (n=10,7,6)
|
105.28 pg/mL
Standard Deviation 490.97
|
1251.14 pg/mL
Standard Deviation 580.38
|
948.97 pg/mL
Standard Deviation 538.67
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
VIP Migraine Headache Free (n=9,4,6)
|
964.4 pg/mL
Standard Deviation 711.43
|
1409.75 pg/mL
Standard Deviation 567.81
|
643.0 pg/mL
Standard Deviation 204.69
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
VIP 24 Hours Migraine Headache Free (n=10,7,5)
|
1059.9 pg/mL
Standard Deviation 564.42
|
1480.79 pg/mL
Standard Deviation 624.74
|
1174.2 pg/mL
Standard Deviation 660.26
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
PGE2 Migraine Onset (n=10,7,6)
|
7.56 pg/mL
Standard Deviation 2.61
|
14.13 pg/mL
Standard Deviation 9.48
|
11.72 pg/mL
Standard Deviation 5.02
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
PGE2 Migraine Headache Free (n=10,4,6)
|
8.35 pg/mL
Standard Deviation 6.52
|
7.87 pg/mL
Standard Deviation 1.44
|
10.21 pg/mL
Standard Deviation 8.82
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
PGE2 24 Hours Migraine Headache Free (n=10,7,7)
|
10.46 pg/mL
Standard Deviation 11.43
|
13.43 pg/mL
Standard Deviation 14.38
|
12.65 pg/mL
Standard Deviation 10.31
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Cortisol Migraine Onset (n=8,7,6)
|
1084.5 pg/mL
Standard Deviation 758.46
|
952.52 pg/mL
Standard Deviation 864.35
|
1508.97 pg/mL
Standard Deviation 2576.41
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Cortisol Migraine Headache Free (n=10,3,5)
|
1490.92 pg/mL
Standard Deviation 2232.7
|
592.35 pg/mL
Standard Deviation 316.8
|
2042.87 pg/mL
Standard Deviation 2363.89
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Cortisol 24 Hours Migraine Headache Free(n=10,6,6)
|
1031.16 pg/mL
Standard Deviation 1474.05
|
863.09 pg/mL
Standard Deviation 687.42
|
1621.38 pg/mL
Standard Deviation 2110.87
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
PGI2 Migraine Onset (n=10,7,6)
|
108.23 pg/mL
Standard Deviation 61.25
|
134.40 pg/mL
Standard Deviation 71.0
|
186.17 pg/mL
Standard Deviation 79.71
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
PGI2 Migraine Headache Free (n=10,4,6)
|
115.63 pg/mL
Standard Deviation 78.71
|
154.16 pg/mL
Standard Deviation 68.28
|
176.37 pg/mL
Standard Deviation 113.87
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
PGI2 24 Hours Migraine Headache Free (n=10,7,7)
|
97.69 pg/mL
Standard Deviation 63.84
|
154.10 pg/mL
Standard Deviation 71.61
|
295.07 pg/mL
Standard Deviation 197.73
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Estradiol Migraine Onset (n=9,7,6)
|
37.75 pg/mL
Standard Deviation 31.67
|
44.89 pg/mL
Standard Deviation 41.81
|
42.81 pg/mL
Standard Deviation 34.04
|
|
Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
Estradiol Migraine Headache Free (n=9,5,4)
|
48.83 pg/mL
Standard Deviation 48.82
|
56.59 pg/mL
Standard Deviation 67.39
|
26.58 pg/mL
Standard Deviation 15.60
|
SECONDARY outcome
Timeframe: From Baseline to 24 hours post headache gone for 1 menstrual migraine.Population: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
CGRP Migraine Onset (n=10,7,6)
|
22.28 pmol/mg
Standard Deviation 14.45
|
22.74 pmol/mg
Standard Deviation 11.94
|
33.76 pmol/mg
Standard Deviation 54.55
|
|
CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
CGRP Migraine Headache Free (n=9,4,6)
|
22.55 pmol/mg
Standard Deviation 30.87
|
49.48 pmol/mg
Standard Deviation 49.68
|
20.78 pmol/mg
Standard Deviation 17.73
|
|
CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
CGRP 24 Hours Migraine Headache Free (n=9,7,7)
|
29.37 pmol/mg
Standard Deviation 26.76
|
28.43 pmol/mg
Standard Deviation 25.46
|
35.87 pmol/mg
Standard Deviation 31.41
|
SECONDARY outcome
Timeframe: From Baseline from 24 hours post migraine gone for 1 menstrual migraine.Population: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
α-amylase Migraine Onset (n=10,7,6)
|
100956.7 U/L
Standard Deviation 13551.51
|
103478.94 U/L
Standard Deviation 10789.63
|
93456.77 U/L
Standard Deviation 14086.08
|
|
α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
α-amylase Migraine Headache Free (n=9,7,7)
|
102908.61 U/L
Standard Deviation 11522.83
|
98720.95 U/L
Standard Deviation 13045.21
|
103031.44 U/L
Standard Deviation 3793.21
|
|
α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
α-amylase 24 Hours Migraine Headache Free(n=10,4,6
|
100354.3 U/L
Standard Deviation 16608.96
|
102475.8 U/L
Standard Deviation 9769.4
|
101559.9 U/L
Standard Deviation 8532.96
|
SECONDARY outcome
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine until headache free.Population: Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.
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.
Outcome measures
| Measure |
Placebo
n=10 Participants
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.
|
Treximet
n=7 Participants
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.
|
Treximet Non-Responder
n=7 Participants
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.
Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.
Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
|
|---|---|---|---|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Urine Pre-Cycle Day 2 (n=6,3,5)
|
4333.92 pg/mL
Standard Deviation 2982.35
|
875.34 pg/mL
Standard Deviation 377.69
|
3661.52 pg/mL
Standard Deviation 3215.32
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Urine Pre-Cycle Day 3 (n=8,2,5)
|
3582.92 pg/mL
Standard Deviation 4121.17
|
3739.44 pg/mL
Standard Deviation 1536.97
|
5629.71 pg/mL
Standard Deviation 6940.06
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Urine Pre-Cycle Day 1 (n=3,2,4)
|
2442.44 pg/mL
Standard Deviation 545.38
|
1898.63 pg/mL
Standard Deviation 92.07
|
3687.07 pg/mL
Standard Deviation 2728.27
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Urine Pre-Cycle Day 4 (n=9,5,5)
|
3232.10 pg/mL
Standard Deviation 2941.52
|
2016.99 pg/mL
Standard Deviation 1295.30
|
4266.02 pg/mL
Standard Deviation 2535.29
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Urine Migraine Headache Free (n=10,7,7)
|
2398.55 pg/mL
Standard Deviation 1872.88
|
2542.09 pg/mL
Standard Deviation 3152.52
|
3373.40 pg/mL
Standard Deviation 4536.70
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Saliva Pre-Cycle Day 1 (n=1,0,4)
|
41.75 pg/mL
Standard Deviation NA
Only one Subject's level was reported for this time point, therefore; mean and standard deviation could not be calculated.
|
NA pg/mL
Standard Deviation NA
Unable to report for this group and time point as samples were not provided by any subjects in this group. Therefore, the mean and standard deviation could not be calculated.
|
43.33 pg/mL
Standard Deviation 23.19
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Saliva Pre-Cycle Day 2 (n=2,2,4)
|
63.45 pg/mL
Standard Deviation 57.60
|
30.89 pg/mL
Standard Deviation 7.16
|
47.36 pg/mL
Standard Deviation 19.65
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Saliva Pre-Cycle Day 3 (n=8,4,7)
|
46.47 pg/mL
Standard Deviation 34.73
|
81.05 pg/mL
Standard Deviation 60.64
|
67.76 pg/mL
Standard Deviation 61.65
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Saliva Pre-Cycle Day 4 (n=8,5,4)
|
55.86 pg/mL
Standard Deviation 50.17
|
31.71 pg/mL
Standard Deviation 26.78
|
54.22 pg/mL
Standard Deviation 36.69
|
|
Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
Saliva Migraine Headache Free (n=8,3,4)
|
54.93 pg/mL
Standard Deviation 48.38
|
75.45 pg/mL
Standard Deviation 68.38
|
33.22 pg/mL
Standard Deviation 5.48
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Treximet
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=20 participants at risk
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.
|
Treximet
n=21 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Dull Stomach Ache
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Left Side Jaw Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Dry Mouth
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Feeling of Upper Body Heaviness
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Dizziness
|
5.0%
1/20 • Number of events 2
|
14.3%
3/21 • Number of events 4
|
|
General disorders
Drowsiness
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right Leg Cramping
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Shakiness
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Worsening Headache
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Right Foot Pain
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Head Pressure
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Flushing of Neck
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Arms Felt Warm
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Flushing of Face
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Jaw Tightness
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest Tightness
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Hepatobiliary disorders
Abnormal Alanine Aminotransferase (ALT)
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
Additional Information
Dr. Roger Cady
Clinvest/A Division of Banyan Group Inc.
Phone: 417-890-7888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place