sumatriptan and Acute Disease

sumatriptan has been researched along with Acute Disease in 139 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.

Acute Disease: Disease having a short and relatively severe course.

Research

Studies (139)

Authors

Clinical Trials (11)

Trial Overview

Trial Outcomes

Number of Participants Free From Headache Pain at 2 Hours After the First Dose of Study Medication Taken for a Migraine Attack With Moderate to Severe Headache Pain During the Double-blind Treatment Period 1 (DB1).

Freedom from headache pain at 2 hours after the first dose of study medication taken within one hour after experiencing a migraine attack of moderate to severe headache pain during the DB1 treatment period, e.g., headache pain rating of moderate [Grade 2] or severe [Grade 3] predose and reduced to none [Grade 0] postdose). Mild headache pain was recorded as Grade 1. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. If the subject experienced insufficient relief from the first dose of study medication, they were permitted to take a second dose of study medication or rescue medication 2 or more hours after the first dose, and only after completing the 2 hours' postdose assessments. If no relief was experienced from the first dose of study medication after 2 hours only rescue medication could be administered. Maximum 2 doses of study medication per 24 hours. (NCT02856802)
Timeframe: 2 hours after study medication administration

Number of Participants With Absence of Most Bothersome Symptom (MBS) Among Nausea, Photophobia and Phonophobia at 2 Hours (DB1)

Number of participants with their MBS among nausea, photophobia and phonophobia absent at 10, 15, 20, 30, 60, 90, and 120 minutes after the first dose of study medication taken for a migraine attack during DB1 treatment period are summarized by treatment group and time point for the full analysis set (FAS1). The corresponding p-values from Fisher's exact test were computed for the comparison between treatment groups. Subjects who reported a MBS predose and reported the status of the MBS at the particular postdose time point were analyzed. (NCT02856802)
Timeframe: 2 hours after study medication administration

Number of Participants With Headache Pain Freedom at 2 Hours Postdose in the Double-blind Treatment Period 2 (DB2)

In Double-blind Treatment Period 2 (DB2), freedom from headache pain 2 hours after the first dose of study medication taken within one hour of experiencing a migraine attack for any headache pain level, e.g., mild [Grade 1], moderate [Grade 2], or severe [Grade 3] and reduced to none [Grade 0] after study medication administration. If the subject was not able to use study medication for the first migraine after randomization, they were instructed to use the study medication for the next attack. (NCT02856802)
Timeframe: 2 hours after study medication administration

Number of Pain Free Participants (Pain Freedom) at 2 Hours Post-dose

"Pain freedom was defined as participants reporting a value of none on the four-point numeric rating scale (none=0, mild =1, moderate =2, severe =3) from baseline. Participants with baseline moderate pain or severe pain were included in the analysis." (NCT01430442)
Timeframe: Baseline, 2 hours post-dose

Number of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours Post Dose

"Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are none on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a Cochran Mantel Haenszel (CMH) test for general association that compares the ED90 to placebo, and controls for baseline pain severity." (NCT01430442)
Timeframe: 2 hours to 24 hours post dose

Number of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours Post Dose

"Participants were considered to have sustained pain freedom if all of their reported pain readings in the interval are none on the four point numeric rating scale (no pain=0, mild pain=1, moderate pain=2, severe pain=3). The intervals are inclusive of the endpoints. Sustained pain freedom was analyzed with a CMH test for general association that compares the ED90 to placebo, and controls for baseline pain severity." (NCT01430442)
Timeframe: 2 hours to 48 hours post dose

Number of Participants With Total Migraine Freedom at 2 Hours Post Dose

"Total migraine freedom is defined as complete absence of migraine symptoms. A participant was positive for total migraine freedom at a particular time point if he/she reports the absence of: pain, nausea, photophobia, and phonophobia. This corresponds to reporting none on each of the four-point numeric rating scale (none =0, mild =1, moderate =2, severe =3) from baseline associated with these symptoms. Participants with baseline moderate pain or severe pain were included in the analysis." (NCT01430442)
Timeframe: Baseline, 2 hours post dose

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuation Due to Adverse Events

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition, unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or suspected transmission of an infectious agent, or encompassed any other clinically significant event that could jeopardize the subject or require medical or surgical intervention to prevent one of the aforementioned outcomes. (NCT01430442)
Timeframe: AEs: from first dose to end of treatment visit (up to 7 weeks); SAE: from signing of informed consent to 30 days after the last dose (up to 11 weeks).

Change in Scores From Completeness of Response Survey (CORS)

"CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.~The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication)." (NCT00893737)
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)

Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction. (NCT00893737)
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan

CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours. (NCT00893737)
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month

The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Mean Blood Pressure for All Study Participants at the Indicated Time Points

At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure. (NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points

BMI = (Weight in kilograms)/(height in centimeters/100)^2 (NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12

The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status. (NCT00488514)
Timeframe: Baseline and Months 3, 6, 9, and 12

Mean Heart Rate for All Study Participants at the Indicated Time Points

A sitting heart rate was measured once for each participant at each visit. (NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

Mean Height for All Study Participants at the Indicated Time Points

(NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

Mean Weight for All Study Participants at the Indicated Time Points

(NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

Number of Migraine Attacks Rated With the Indicated Pain Severity

The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12

"The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7)." (NCT00488514)
Timeframe: End of Study/Month 12

Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit

"The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7)." (NCT00488514)
Timeframe: Screening

Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator

The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator. (NCT00488514)
Timeframe: Screening and Final Visit (up to Month 12)

Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit

"A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL)." (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Any Adverse Event Categorized by Participant Age

The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Any Adverse Event Categorized by Participant Gender

The number of participants with adverse events by gender is recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Any Adverse Event Categorized by Participant Race

"The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White." (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Any Adverse Event Categorized by Severity

The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Any Adverse Event Categorized Over Time

The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet

The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit

"A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490." (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Participants With the Indicated Drug-related Adverse Events

The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: >=2% participants recorded as having at least one occurrence of a reported drug-related AE. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet

The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet

The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Treated Migraine Attacks

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting

The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Reviews

47 reviews available for sumatriptan and Acute Disease

Trials

53 trials available for sumatriptan and Acute Disease

Other Studies

39 other studies available for sumatriptan and Acute Disease