A clinical trial to study the effects of Almotriptan oral tablets in patients with Migraine Headache

INTERVENTION: Intervention1: Almotriptan 12.5 mg Tablet: 12.5mg Control Intervention1: Sumatriptan 50mg Tablet: 50mg CONDITION: Migraine headache PRIMARY OUTCOME: Effectiveness: pain free at 2 hours (defined as a decrease from severe, moderate or mild to no pain) without the use of supplemental pain medication and/or antiemetic medication up to the 2 hour timepoint ? Pain as recorded by the patient in a daily diary; rating was based on an 11‐point Likert‐like numerical scale that ranged from 0 (no pain) to 10 (worst possible pain) The primary safety variable for this clinical trial is to compare the safety and tolerability of the study drugs. The number of adverse events in each arm will be documented to evaluate the safety profile‐‐‐‐‐‐Timepoint: 2 hours SECONDARY OUTCOME: Effectiveness: time to pain free post‐dosing; timed assessments to achieve pain relief at 0.5, 1, 2, 4 and 24 hours post‐dosing; consistency of response; migraine‐associated symptoms; migraine‐associated vomiting; change in functional disability, ? Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) administered at the completion visit. This includes clinical laboratory tests (hematology, biochemistry, and urinalysis), physical examinations, vital signs (body temperature, heart rate, respiratory rate, and blood pressure), and 12‐lead electrocardiograms. The clinical laboratory tests (complete blood count, kidney function, aminotransferases and alkaline phosphatase) will be performed by a central laboratory at the time of screening and at the time of completion of the study.‐‐‐‐‐‐Timepoint: 0.5, 1, 2, 4 and 24 hours INCLUSION CRITERIA:  All subjects with duly filled and signed in ICFs [Informed Consent Forms]  Male and female outpatients ³ 18 years of age.  Diagnosis of migraine, with or without aura  At least moderate pain with migraines  Average of 2 to 6 migraines per month for past 3 months  Duration of headache pain at least 4 hours  Able to tell the difference between a migraine and a tension headache  If taking a medication to prevent migraines, patients must have been taking a maintenance dose for at least 30 days before screening  In generally good health  If female, using birth control  Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.