sumatriptan has been researched along with Sinusitis in 1 studies
Sumatriptan: A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.
sumatriptan : A sulfonamide that consists of N,N-dimethyltryptamine bearing an additional (N-methylsulfamoyl)methyl substituent at position 5. Selective agonist for a vascular 5-HT1 receptor subtype (probably a member of the 5-HT1D family). Used (in the form of its succinate salt) for the acute treatment of migraine with or without aura in adults.
Sinusitis: Inflammation of the NASAL MUCOSA in one or more of the PARANASAL SINUSES.
Excerpt | Relevance | Reference |
---|---|---|
"Secretion of calcitonin gene-related peptide (CGRP) from trigeminal nerves and vasoactive intestinal peptide (VIP) from parasympathetic nerves is involved in the pathophysiology of migraine and rhinosinusitis." | 3.73 | Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients. ( Bellamy, JL; Cady, RK; Durham, PL, 2006) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (100.00) | 29.6817 |
2010's | 0 (0.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Bellamy, JL | 1 |
Cady, RK | 1 |
Durham, PL | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Evaluation of CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Saliva of Menstrual Migraine Patients Before and After Treatment With Treximet™[NCT01329562] | Phase 4 | 41 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
Calcitonin Gene-related Peptide (CGRP) Levels in the Pathogenesis of Chronic Migraine[NCT01071096] | Phase 4 | 20 participants (Actual) | Interventional | 2010-06-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"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." (NCT01329562)
Timeframe: From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.
Intervention | participants (Number) |
---|---|
Placebo | 0 |
Treximet | 2 |
"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." (NCT01329562)
Timeframe: From the onset of 1 menstrual migraine until 24 hours post treatment.
Intervention | participants (Number) |
---|---|
Placebo | 1 |
Treximet Responder | 2 |
Treximet Non-Responder | 0 |
"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." (NCT01329562)
Timeframe: From onset of 1 menstrual migraine headache until pain free.
Intervention | hours (Mean) |
---|---|
Placebo | 7.64 |
Treximet | 3.90 |
"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." (NCT01329562)
Timeframe: From the onset of 1 menstrual migraine headache until pain-free.
Intervention | hours (Mean) |
---|---|
Placebo | 7.64 |
Treximet Responder | 3.13 |
Treximet Non-Responder | 4.68 |
"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." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache
Intervention | pg/mL (Mean) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
VIP Baseline (n=10, 14) | VIP Migraine Onset (n=10, 13) | VIP 2 Hours Post Treatment (n=9, 13) | PGE2 Baseline (n=10, 14) | PGE2 Migraine Onset (n=10, 13) | PGE2 2 Hours Post Treatment (n=9, 14) | Cortisol Baseline (n=10, 13) | Cortisol Migraine Onset (n=8, 13) | Cortisol 2 Hours Post Treatment (n=8, 10) | PGI2 Baseline (n=10, 14) | PGI2 Migraine Onset (n=10, 13) | PGI2 2 Hours Post Treatment (n=9, 14) | Estradiol Baseline (n=10, 13) | Estradiol Migraine Onset (n=9, 13) | Estradiol 2 Hours Post Treatment (n=9,14) | |
Placebo | 763.6 | 1052.8 | 1130.44 | 9.25 | 7.56 | 8.29 | 1064.14 | 1084.85 | 2011.45 | 109.51 | 108.23 | 97.58 | 63.37 | 41.68 | 54.07 |
Treximet | 1149.5 | 1111.31 | 933.77 | 12.65 | 13.02 | 7.99 | 1040.49 | 1209.34 | 418.48 | 160.27 | 158.29 | 201.60 | 62.61 | 43.93 | 41.66 |
"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." (NCT01329562)
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.
Intervention | pg/mL (Mean) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
VIP Baseline (n=10,7,7) | VIP Migraine Onset (n=10,7,6) | VIP 2 Hours Post Treatment (n=9,7,6,) | PGE2 Baseline (n=10,7,7) | PGE2 Migraine Onset (n=10,7,6) | PGE2 2 Hours Post Treatment (n=9,7,7) | Cortisol Baseline (n=10,6,7) | Cortisol Migraine Onset (n=8,7,6) | Cortisol 2 Hours Post Treatment (n=8,6,4) | PGI2 Baseline (n=10,7,7) | PGI2 Migraine Onset (n=10,7,6) | PGI2 2 Hours Post Treatment (n=9,7,7) | Estradiol Baseline (n=9,7,6) | Estradiol Migraine Onset (n=8,7,6) | Estradiol 2 Hours Post Treatment (n=8,7,7) | |
Placebo | 763.6 | 1052.8 | 1130.44 | 9.25 | 7.56 | 8.29 | 1064.14 | 1084.5 | 2011.45 | 109.51 | 108.23 | 97.58 | 63.37 | 37.05 | 54.07 |
Treximet Non-Responder | 885.0 | 948.17 | 414.0 | 11.01 | 11.72 | 9.15 | 1254.53 | 1508.97 | 322.72 | 177.54 | 186.17 | 247.63 | 66.68 | 42.81 | 46.68 |
Treximet Responder | 1414.0 | 1251.14 | 1320.14 | 14.29 | 14.13 | 6.83 | 790.77 | 952.52 | 482.32 | 142.99 | 134.40 | 155.56 | 49.60 | 44.89 | 36.64 |
"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." (NCT01329562)
Timeframe: From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days
Intervention | pg/mL (Mean) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
VIP Migraine Onset (n=10,7,6) | VIP Migraine Headache Free (n=9,4,6) | VIP 24 Hours Migraine Headache Free (n=10,7,5) | PGE2 Migraine Onset (n=10,7,6) | PGE2 Migraine Headache Free (n=10,4,6) | PGE2 24 Hours Migraine Headache Free (n=10,7,7) | Cortisol Migraine Onset (n=8,7,6) | Cortisol Migraine Headache Free (n=10,3,5) | Cortisol 24 Hours Migraine Headache Free(n=10,6,6) | PGI2 Migraine Onset (n=10,7,6) | PGI2 Migraine Headache Free (n=10,4,6) | PGI2 24 Hours Migraine Headache Free (n=10,7,7) | Estradiol Migraine Onset (n=9,7,6) | Estradiol Migraine Headache Free (n=9,5,4) | Estradiol 24 Hours Migraine Headache Free(n=6,7,6) | |
Placebo | 105.28 | 964.4 | 1059.9 | 7.56 | 8.35 | 10.46 | 1084.5 | 1490.92 | 1031.16 | 108.23 | 115.63 | 97.69 | 37.75 | 48.83 | 21.34 |
Treximet Non-Responder | 948.97 | 643.0 | 1174.2 | 11.72 | 10.21 | 12.65 | 1508.97 | 2042.87 | 1621.38 | 186.17 | 176.37 | 295.07 | 42.81 | 26.58 | 81.38 |
Treximet Responder | 1251.14 | 1409.75 | 1480.79 | 14.13 | 7.87 | 13.43 | 952.52 | 592.35 | 863.09 | 134.40 | 154.16 | 154.10 | 44.89 | 56.59 | 34.86 |
"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." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache.
Intervention | pg/mL (Mean) | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
VIP Migraine Onset (n=10,7,6) | VIP Migraine Headache Free (n=9,4,7) | VIP 24 Hours Migraine Headache Free (n=10,7,6) | PGE2 Migraine Onset (n=10,7,6) | PGE2 Migraine Headache Free (n=10,4,6,) | PGE2 24 Hours Migraine Headache Free (n=10,7,7) | Cortisol Migraine Onset (n=8,7,6) | Cortisol Migraine Headache Free (n=10,3,6) | Cortisol 24 Hours Migraine Headache Free(n=10,6,6) | PGI2 Migraine Onset (n=10,7,6) | PGI2 Migraine Headache Free (n=10,4,6) | PGI2 24 Hours Migraine Headache Free (n=10,7,7) | Estradiol Migraine Onset (n=9,7,6) | Estradiol Migraine Headache Free (n=9,4,5,) | Estradiol 24 Hours Migraine Headache Free(n=6,7,5) | |
Placebo | 1052.8 | 964.4 | 1059.9 | 7.56 | 8.35 | 10.46 | 1084.5 | 1490.92 | 1031.16 | 108.23 | 115.63 | 97.69 | 37.05 | 48.83 | 21.34 |
Treximet | 1111.31 | 949.7 | 1353.04 | 13.02 | 9.27 | 13.04 | 1209.34 | 1498.92 | 1271.4 | 158.29 | 167.48 | 224.58 | 43.93 | 39.92 | 56.33 |
"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." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headache
Intervention | pmol/mg (Mean) | ||
---|---|---|---|
CGRP Baseline (n=10, 14) | CGRP Migraine Onset (n=10, 13) | CGRP 2 Hours Post Treatment (n=9, 14) | |
Placebo | 18.55 | 22.28 | 14.92 |
Treximet | 15.03 | 27.82 | 21.38 |
"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." (NCT01329562)
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.
Intervention | pmol/mg (Mean) | ||
---|---|---|---|
CGRP Baseline (n=10,7,7) | CGRP Migraine Onset (n=10,7,6) | CGRP 2 Hours Post Treatment (n=9,7,7) | |
Placebo | 18.55 | 22.28 | 14.92 |
Treximet Non-Responder | 17.80 | 33.76 | 21.67 |
Treximet Responder | 12.27 | 22.74 | 21.08 |
"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." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache
Intervention | pmol/mg (Mean) | ||
---|---|---|---|
CGRP Migraine Onset (n=10,7,6) | CGRP Migraine Headache Free (n=9,4,6) | CGRP 24 Hours Migraine Headache Free (n=9,7,7) | |
Placebo | 22.28 | 22.55 | 29.37 |
Treximet | 28.82 | 32.26 | 32.15 |
"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." (NCT01329562)
Timeframe: From Baseline to 24 hours post headache gone for 1 menstrual migraine.
Intervention | pmol/mg (Mean) | ||
---|---|---|---|
CGRP Migraine Onset (n=10,7,6) | CGRP Migraine Headache Free (n=9,4,6) | CGRP 24 Hours Migraine Headache Free (n=9,7,7) | |
Placebo | 22.28 | 22.55 | 29.37 |
Treximet Non-Responder | 33.76 | 20.78 | 35.87 |
Treximet Responder | 22.74 | 49.48 | 28.43 |
"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." (NCT01329562)
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free
Intervention | pg/mL (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Urine Pre-Cycle Day 1 (n=3, 6) | Urine Pre-Cycle Day 2 (n=6, 8) | Urine Pre-Cycle Day 3 (n=8, 6) | Urine Pre-Cycle Day 4 (n=9, 10) | Urine Migraine Headache Free (n=11, 13 | Saliva Pre-Cycle Day 1 (n=1, 4) | Saliva Pre-Cycle Day 2 (n=2, 6) | Saliva Pre-Cycle Day 3 (n=8, 10) | Saliva Pre-Cycle Day 4 (n=6, 9) | Saliva Migraine Headache Free (n=8, 6) | |
Placebo | 2442.44 | 4333.92 | 3582.92 | 3232.10 | 2398.55 | 41.75 | 63.45 | 46.47 | 55.86 | 54.93 |
Treximet | 3090.92 | 2616.64 | 5089.63 | 3141.51 | 2989.72 | 43.33 | 41.87 | 73.08 | 41.72 | 51.32 |
"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." (NCT01329562)
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine until headache free.
Intervention | pg/mL (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Urine Pre-Cycle Day 1 (n=3,2,4) | Urine Pre-Cycle Day 2 (n=6,3,5) | Urine Pre-Cycle Day 3 (n=8,2,5) | Urine Pre-Cycle Day 4 (n=9,5,5) | Urine Migraine Headache Free (n=10,7,7) | Saliva Pre-Cycle Day 1 (n=1,0,4) | Saliva Pre-Cycle Day 2 (n=2,2,4) | Saliva Pre-Cycle Day 3 (n=8,4,7) | Saliva Pre-Cycle Day 4 (n=8,5,4) | Saliva Migraine Headache Free (n=8,3,4) | |
Placebo | 2442.44 | 4333.92 | 3582.92 | 3232.10 | 2398.55 | 41.75 | 63.45 | 46.47 | 55.86 | 54.93 |
Treximet Non-Responder | 3687.07 | 3661.52 | 5629.71 | 4266.02 | 3373.40 | 43.33 | 47.36 | 67.76 | 54.22 | 33.22 |
Treximet Responder | 1898.63 | 875.34 | 3739.44 | 2016.99 | 2542.09 | NA | 30.89 | 81.05 | 31.71 | 75.45 |
"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." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headache
Intervention | U/L (Mean) | ||
---|---|---|---|
α-Amylase Baseline (n=10, 14) | α-Amylase Migraine Onset (n=10, 13) | α-Amylase 2 Hours Post Treatment (n=9, 14) | |
Placebo | 109280.50 | 100956.70 | 102449.80 |
Treximet | 99626.61 | 98853.32 | 103594.90 |
"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." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache.
Intervention | U/L (Mean) | ||
---|---|---|---|
α-Amylase Baseline (n=10,7,7) | α-Amylase Migraine Onset (n=10,7,6) | α-Amylase 2 Hours Post Treatment (n=9,7,7) | |
Placebo | 109280.50 | 100956.7 | 102449.88 |
Treximet Non-Responder | 101250.54 | 93456.77 | 103662.4 |
Treximet Responder | 98002.68 | 103478.94 | 103527.5 |
"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." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache
Intervention | U/L (Mean) | ||
---|---|---|---|
α-Amylase Migraine Onset (n=10,7,6) | α-Amylase Migraine Headache Free (n=10,4,6) | α-Amylase 24 Hours Migraine Headache Free(n=10,7,7 | |
Placebo | 100956.70 | 102908.61 | 100354.00 |
Treximet | 98853.32 | 101307.25 | 102017.80 |
"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." (NCT01329562)
Timeframe: From Baseline from 24 hours post migraine gone for 1 menstrual migraine.
Intervention | U/L (Mean) | ||
---|---|---|---|
α-amylase Migraine Onset (n=10,7,6) | α-amylase Migraine Headache Free (n=9,7,7) | α-amylase 24 Hours Migraine Headache Free(n=10,4,6 | |
Placebo | 100956.7 | 102908.61 | 100354.3 |
Treximet Non-Responder | 93456.77 | 103031.44 | 101559.9 |
Treximet Responder | 103478.94 | 98720.95 | 102475.8 |
Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary. (NCT01071096)
Timeframe: Baseline (collected historically at screening) versus (vs.) Month (Mo) 1, Mo 2, Mo 3, Mo 4, Mo 5, Mo 6, and Mo 7
Intervention | days (Mean) | ||||||
---|---|---|---|---|---|---|---|
Baseline vs. Month 1 | Baseline vs. Month 2 | Baseline vs. Month 3 | Baseline vs. Month 4 | Baseline vs. Month 5 | Baseline vs. Month 6 | Baseline vs. Month 7 | |
Group A | -7.61 | -9.72 | -10.06 | -9.50 | -8.94 | -9.50 | -6.50 |
Group B | -6.67 | -5.22 | -5.22 | -6.89 | -6.33 | -9.22 | -4.56 |
Baseline number of headache days per month collected historically at screening. Post-treatment number of headache days collected per month via diary. (NCT01071096)
Timeframe: Baseline (collected historically at screening) vs. Mo 1, Mo 1 vs. Mo 2, Mo 2 vs. Mo 3, Mo 3 vs. Mo 4, Mo 4 vs. Mo 5, Mo 5 vs. Mo 6, and Mo 6 vs. Mo 7
Intervention | days (Mean) | ||||||
---|---|---|---|---|---|---|---|
Baseline vs. Mo 1 | Mo 1 vs. Mo 2 | Mo 2 vs. Mo 3 | Mo 3 vs. Mo 4 | Mo 4 vs. Mo 5 | Mo 5 vs. Mo 6 | Mo 6 vs. M 7 | |
Group A | -7.61 | -2.11 | -0.33 | 0.56 | 0.56 | -0.56 | 3.00 |
Group B | -6.67 | 1.44 | 0.00 | -1.67 | 0.56 | -2.89 | 4.67 |
Only cytokines with a mean densimetric value 1.65 times the background grey value in a minimum of 3 patients were considered detectable. These are reported below. Values normalized to positive control array spots after background subtraction: C5/C5a, CD40 Ligand, Granulocyte Colony Stimulating Factor (G-CSF), Growth Regulated Oncogene(GRO)-alpha, Soluble Intercellular Adhesion Molecule (sICAM)-1, Interferon gamma (IFN-y), Interleukin(IL)-1alpha, 1beta, 1ra, 8, 16, 17E, & 23, Interferon Gamma-Induced Protein 10 (IP-10), Interferon-inducible T cell alpha chemoattractant (I-TAC), Macrophage Migration Inhibitory Factor (MIF), Serpin E1, and Regulated Upon Activation Normal T-cell Expressed (RANTES) (NCT01071096)
Timeframe: For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3 at Baseline level (inter-ictal) and at onset of headache that is one degree worse than Baseline level and that will be treated with acute therapy
Intervention | Florescent Units (FU) (Mean) | |||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
C5/C5a | CD40 Ligand | G-CSF | GROa | sICAM-1 | IFN-y | IL-1alpha | IL-1beta | IL-1ra | IL-8 | IL-16 | IL-17E | IL-23 | IP-10 | I-TAC | MIF | Serpin E1 | RANTES | |
Month 1 vs. Month 3 Non-Responders | 3.26 | 1.22 | 1.34 | 0.73 | 1.51 | 1.63 | 0.81 | 1.03 | 1.30 | 2.28 | 1.10 | 1.45 | 2.61 | 3.11 | 3.65 | 1.24 | 3.16 | 1.24 |
Month 1 vs. Month 3 Responders | 1.03 | 0.91 | 1.07 | 1.05 | 3.99 | 0.91 | 0.86 | 1.15 | 0.88 | 4.38 | 0.98 | 1.28 | 0.93 | 1.55 | 0.67 | 0.80 | 0.76 | 1.14 |
Month 1 vs. Saline Non-Responders | 1.01 | 1.26 | 0.93 | 3.18 | 0.61 | 0.80 | 2.88 | 1.12 | 2.02 | 1.70 | 2.07 | 1.02 | 1.80 | 0.95 | 0.28 | 9.55 | 0.70 | 0.77 |
Month 1 vs. Saline Responders | 1.38 | 1.09 | 0.92 | 1.34 | 2.60 | 1.29 | 2.30 | 1.63 | 1.13 | 1.61 | 0.91 | 0.86 | 2.45 | 1.32 | 1.40 | 3.71 | 0.98 | 0.95 |
Month 3 vs. Saline Non-Responders | 1.61 | 1.31 | 0.99 | 1.81 | 2.00 | 1.92 | 2.14 | 0.51 | 1.90 | 1.22 | 1.97 | 0.42 | 1.69 | 2.76 | 0.94 | 8.66 | 0.90 | 0.91 |
Month 3 vs. Saline Responders | 1.39 | 0.98 | 0.85 | 1.40 | 5.99 | 1.29 | 1.50 | 1.38 | 0.96 | 2.71 | 0.75 | 1.59 | 1.06 | 0.86 | 1.01 | 2.71 | 0.70 | 0.93 |
CGRP Level collected each month when subject did not have a headache or was at lowest pain level of headache that month. (NCT01071096)
Timeframe: Baseline levels collected for OnabotulinumtoxinA and Saline treatment during Months 1 through 7
Intervention | pmol/mg total protein (Mean) | ||
---|---|---|---|
Treatment Month 1 | Treatment Month 2 | Treatment Month 3 | |
OnabotulinumtoxinA | 39.64 | 28.37 | 26.14 |
Saline | 40.79 | 39.14 | 50.63 |
Saliva samples collected at Baseline (at no headache or lowest level of headache), at headache attack directly before taking rescue medication and 2 hours after treating with rescue medication. (NCT01071096)
Timeframe: For OnabotulinumtoxinA and Saline treatment months 1, 2 and 3
Intervention | pmol/mg total protein (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Treatment Month 1 - Baseline | Treatment Month 1 - Attack | Treatment Month 1 - 2 Hours Post | Treatment Month 2 - Baseline | Treatment Month 2 - Attack | Treatment Month 2 - 2 Hours Post | Treatment Month 3 - Baseline | Treatment Month 3 - Attack | Treatment Month 3 - 2 Hours Post | |
OnabotulinumtoxinA Non-Responders | 29.36 | 22.36 | 23.66 | 28.66 | 32.65 | 22.35 | 32.61 | 30.17 | 19.11 |
OnabotulinumtoxinA Responders | 52.36 | 27.94 | 61.55 | 59.89 | 60.14 | 39.13 | 51.33 | 73.18 | 54.04 |
Saline | 70.46 | 36.23 | 39.76 | 44.12 | 33.05 | 33.93 | 58.74 | 46.16 | 49.39 |
1 other study available for sumatriptan and Sinusitis
Article | Year |
---|---|
Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients.
Topics: Adolescent; Adult; Calcitonin Gene-Related Peptide; Ephedrine; Female; Humans; Male; Middle Aged; Mi | 2006 |
Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients.
Topics: Adolescent; Adult; Calcitonin Gene-Related Peptide; Ephedrine; Female; Humans; Male; Middle Aged; Mi | 2006 |
Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients.
Topics: Adolescent; Adult; Calcitonin Gene-Related Peptide; Ephedrine; Female; Humans; Male; Middle Aged; Mi | 2006 |
Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients.
Topics: Adolescent; Adult; Calcitonin Gene-Related Peptide; Ephedrine; Female; Humans; Male; Middle Aged; Mi | 2006 |