sumatriptan and Sinusitis

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.

Research

Studies (1)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Migraine Recurrence

"Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe." (NCT01329562)
Timeframe: From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.

Migraine Recurrence Responders vs Non-Responders

"Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.~0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From the onset of 1 menstrual migraine until 24 hours post treatment.

Time to Pain Free

"Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe." (NCT01329562)
Timeframe: From onset of 1 menstrual migraine headache until pain free.

Time to Pain-Free in Responders vs Non-Responders

"Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.~0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From the onset of 1 menstrual migraine headache until pain-free.

Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

"Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache

Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders

"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.

Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days

Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache.

CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

"CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headache

CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders

"CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.

CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

"CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache

CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

"CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline to 24 hours post headache gone for 1 menstrual migraine.

Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.

"Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point." (NCT01329562)
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free

Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders

"Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine until headache free.

α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headache

α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders

"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache.

α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

"α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache

α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

"α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline from 24 hours post migraine gone for 1 menstrual migraine.

Change in Number of Headache Days Per Month From Baseline (BL) to Months 1 Through 7.

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

Change in Number of Headache Days Per Month From Baseline to Month 1 (M1), Month 1 to Month 2 (M2), and Month 2 to Month 3 (M3).

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

Changes Between Inter-ictal (Baseline) Levels Between Responders and Non-responders

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

Inter-ictal (Baseline) Levels of Saliva Calcitonin Gene-related Peptide (CGRP)

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

Saliva CGRP Levels for OnabotulinumtoxinA Responders (Reduction of Headache Days Greater Than 30%) vs. Non-responders and Saline

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

Other Studies

1 other study available for sumatriptan and Sinusitis