Long-Term Safety of Treximet (Sumatriptan/Naproxen Sodium) for Migraine in Adolescents

• ClinicalTrials.gov Identifier: NCT00488514
• Recruitment Status: Completed
• First Posted: June 20, 2007
• Results First Posted: September 6, 2010
• Last Update Posted: May 18, 2017
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents for the acute treatment of migraine.

Condition or disease	Intervention/treatment	Phase
Migraine Disorders	Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium)	Phase 3

Detailed Description:

This study was designed to determine long-term safety of TREXIMET (sumatriptan/naproxen sodium) in adolescents (aged 12 to 17 years) for the acute treatment of migraine.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 656 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents
• Study Start Date: July 13, 2007
• Actual Primary Completion Date: August 1, 2009
• Actual Study Completion Date: August 20, 2009

Arms and Interventions

Arm	Intervention/treatment
Active Drug; Combination Tablet of Treximet (sumatriptan/naproxen sodium)	Drug: Combination Tablet of Treximet (sumatriptan/naproxen sodium); Combination Tablet of Treximet(sumatriptan/naproxen sodium); Other Name: Combination Product (sumatriptan succinate / naproxen sodium)

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With the Indicated Drug-related Adverse Events [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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.

Secondary Outcome Measures :

1. Number of Participants With Any Adverse Event Categorized by Severity [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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.
2. Number of Participants With Any Adverse Event Categorized Over Time [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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.
3. Number of Participants With Any Adverse Event Categorized by Participant Age [ Time Frame: Baseline through End of Study (up to Month 12) ]
   The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded.
4. Number of Participants With Any Adverse Event Categorized by Participant Race [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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.
5. Number of Participants With Any Adverse Event Categorized by Participant Gender [ Time Frame: Baseline through End of Study (up to Month 12) ]
   The number of participants with adverse events by gender is recorded.
6. Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]
   The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded.
7. Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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.
8. 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 [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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).
9. Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit [ Time Frame: Baseline through End of Study (up to Month 12) ]
   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.
10. Mean Height for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]
11. Mean Weight for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]
12. Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]
    BMI = (Weight in kilograms)/(height in centimeters/100)^2
13. Mean Blood Pressure for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]
    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.
14. Mean Heart Rate for All Study Participants at the Indicated Time Points [ Time Frame: Screening and Months 3, 6, 9, and 12 ]
    A sitting heart rate was measured once for each participant at each visit.
15. Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator [ Time Frame: Screening and Final Visit (up to Month 12) ]
    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.
16. Number of Treated Migraine Attacks [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
17. Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
18. Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
19. 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 [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
20. Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
21. Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet [ Time Frame: Baseline through End of Study (up to Month 12) ]
    The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized.
22. Number of Migraine Attacks Rated With the Indicated Pain Severity [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
23. Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting [ Time Frame: Baseline through End of Study (up to Month 12) ]
    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.
24. 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 [ Time Frame: Baseline and 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.
25. 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 [ Time Frame: Screening ]
    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).
26. 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 [ Time Frame: End of Study/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).

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Subject is between 12 and 17 years old at the Screening visit.
• If subject is female, she must have a negative urine pregnancy test at screening, does not plan to become pregnant during the course of the study and agrees to use an acceptable method of birth control (i.e., a method with a failure rate <1% or abstinence) if she is/becomes sexually active.
• Subject has migraine with or without aura (2004 ICHD-II criteria).
• Subject has history suggestive of typical migraine attacks with duration of about 2 or more hours (untreated, or unsuccessfully treated).
• Subject has at least 2, but not more than 8, migraine attacks per month in each of the 2 months prior to the Screening visit.
• Subject has at least a 6-month history of moderate to severe migraine attacks, sufficient to establish a definitive diagnosis of migraine.
• Subject is able to distinguish migraine from other headaches (e.g., tension-type headaches).
• Subject and subject's parent or legal guardian are willing and able to provide informed consent prior to entry into this treatment phase of the study.
• Subject and subject's parent or legal guardian are able to read and write English or Spanish.
• Subject is able to understand and complete the electronic device to report treatment information.

Exclusion Criteria:

• Subject is < 75 pounds (33.3kg).
• Subject has ≥15 headache days per month in total, retinal (ICHD-II 1.4), basilar (ICHD-II 1.26) or hemiplegic migraine (ICHD-II 1.25), or secondary headaches.
• Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (See Appendix 1, section 11.1).
• Subject has uncontrolled hypertension (See Appendix 2, section 11.2) or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
• Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
• Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with any of the above.
• Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
• Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
• Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
• Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
• Subject has a recent history of regular use of opioids or barbiturates for treatment of his/her migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
• Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
• Subject history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
• Subject has evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
• Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
• Subject has participated in an investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

Contacts and Locations

Locations

United States, Arizona

GSK Investigational Site

Gilbert, Arizona, United States, 85234

GSK Investigational Site

Phoenix, Arizona, United States, 85014

United States, Arkansas

GSK Investigational Site

Jonesboro, Arkansas, United States, 72401

GSK Investigational Site

Little Rock, Arkansas, United States, 72205

United States, California

GSK Investigational Site

Chico, California, United States, 95926

GSK Investigational Site

Fair Oaks, California, United States, 95628

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Fresno, California, United States, 93720

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Fullerton, California, United States, 92835

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Huntington Beach, California, United States, 92647

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Irvine, California, United States, 92618

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La Jolla, California, United States, 92037

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Newport Beach, California, United States, 92660

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Northridge, California, United States, 91325

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Redondo Beach, California, United States, 90277

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Roseville, California, United States, 95678

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Sacramento, California, United States, 92585

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San Francisco, California, United States, 94109

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Santa Monica, California, United States, 90404

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Walnut Creek, California, United States, 94596

United States, Colorado

GSK Investigational Site

Aurora, Colorado, United States, 80045

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Colorado Springs, Colorado, United States, 80909

United States, Connecticut

GSK Investigational Site

East Hartford, Connecticut, United States, 06118-3239

GSK Investigational Site

Fairfield, Connecticut, United States, 06824

United States, Florida

GSK Investigational Site

Loxahatchee, Florida, United States, 33470

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Naples, Florida, United States, 34102

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Pensacola, Florida, United States, 32504

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St. Petersburg, Florida, United States, 33701

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West Palm Beach, Florida, United States, 33407

United States, Georgia

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Atlanta, Georgia, United States, 30342

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Savannah, Georgia, United States, 31405

United States, Indiana

GSK Investigational Site

Anderson, Indiana, United States, 46011

United States, Kentucky

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Bardstown, Kentucky, United States, 40004

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Murray, Kentucky, United States, 42071

United States, Michigan

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Ann Arbor, Michigan, United States, 48104

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Kalamazoo, Michigan, United States, 49008

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Paw Paw, Michigan, United States, 49079

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Protage, Michigan, United States, 49024

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Richland, Michigan, United States, 49083

United States, Minnesota

GSK Investigational Site

Plymouth, Minnesota, United States, 55441

United States, Missouri

GSK Investigational Site

St. Louis, Missouri, United States, 63141

United States, Nebraska

GSK Investigational Site

Omaha, Nebraska, United States, 68130

United States, Nevada

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Henderson, Nevada, United States, 89014

United States, New Jersey

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New Brunswick, New Jersey, United States, 08901

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Ridgewood, New Jersey, United States, 7450

GSK Investigational Site

Vorhees, New Jersey, United States, 08043

United States, New Mexico

GSK Investigational Site

Albuquerque, New Mexico, United States, 87108

United States, New York

GSK Investigational Site

Albany, New York, United States, 12206

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Amherst, New York, United States, 14226

GSK Investigational Site

Endwell, New York, United States, 13760

GSK Investigational Site

Mount Vernon, New York, United States, 10550

GSK Investigational Site

New York, New York, United States, 10022

GSK Investigational Site

Plainview, New York, United States, 11803

GSK Investigational Site

Rochester, New York, United States, 14609

GSK Investigational Site

Rochester, New York, United States, 14642

GSK Investigational Site

Williamsville, New York, United States, 14221

United States, North Carolina

GSK Investigational Site

Raleigh, North Carolina, United States, 27607

United States, Ohio

GSK Investigational Site

Cincinnati, Ohio, United States, 45229

GSK Investigational Site

Cleveland, Ohio, United States, 44195

GSK Investigational Site

Columbus, Ohio, United States, 43205

GSK Investigational Site

Westerville, Ohio, United States, 43081

United States, Oklahoma

GSK Investigational Site

Oklahoma City, Oklahoma, United States, 73112

United States, Oregon

GSK Investigational Site

Eugene, Oregon, United States, 97401

GSK Investigational Site

Medford, Oregon, United States, 97504-8456

GSK Investigational Site

Portland, Oregon, United States, 97210

United States, South Carolina

GSK Investigational Site

Greer, South Carolina, United States, 29651

United States, Tennessee

GSK Investigational Site

Nashville, Tennessee, United States, 37203

United States, Texas

GSK Investigational Site

Dallas, Texas, United States, 75230

GSK Investigational Site

Georgetown, Texas, United States, 78626

GSK Investigational Site

Nassau Bay, Texas, United States, 77058

GSK Investigational Site

Plano, Texas, United States, 79075

GSK Investigational Site

San Antonio, Texas, United States, 78229

United States, Utah

GSK Investigational Site

Salt Lake City, Utah, United States, 84109

GSK Investigational Site

Salt Lake City, Utah, United States, 84121

United States, Virginia

GSK Investigational Site

Charlottesville, Virginia, United States, 22902

GSK Investigational Site

Norfolk, Virginia, United States, 23510

United States, Washington

GSK Investigational Site

Bremerton, Washington, United States, 98310

GSK Investigational Site

Wenatchee, Washington, United States, 98801

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Individual Participant Data Set 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: TXA107977
For additional information about this study please refer to the GSK Clinical Study Register

Publications:

McDonald SA, Hershey AD, Pearlman E, Lewis D, Winner PK, Rothner D, Linder SL, Runken MC, Richard NE, Derosier FJ. Long-term evaluation of sumatriptan and naproxen sodium for the acute treatment of migraine in adolescents. Headache. 2011 Oct;51(9):1374-87. doi: 10.1111/j.1526-4610.2011.01965.x. Epub 2011 Jul 28.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00488514
• Other Study ID Numbers: TXA107977
• First Posted: June 20, 2007
• Results First Posted: September 6, 2010
• Last Update Posted: May 18, 2017
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Long-term Safety; Migraine; Adolescent Migraine Headache; sumatriptan succinate; naproxen sodium

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Naproxen; Sumatriptan; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Vasoconstrictor Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents