Health Condition 1: null- Migraine headache
Conditions
Interventions
Intervention1: Almotriptan 12.5 mg Tablet: 12.5mg
Control Intervention1: Sumatriptan 50mg Tablet: 50mg
Sponsors
MSN Laboratories Ltd ,115,2 RT (7-1-621/39)
2nd Floor, Sanjeeva Reddy Nagar,
Hyderabad-500038
Eligibility
Inclusion criteria
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.
Exclusion criteria
Exclusion criteria:  Patients unwilling to sign on ICF  Routinely experience other type of headache that might seem like a migraine headache  An average of 15 or more headache days per month in the past 6 months  Migraines began after age 50  Taking 1 medicine for preventing migraines  Use of any drugs on list of prohibited drugs, of opioid drugs in past 7 days, of corticosteroids in the past 30 days, of an investigational drug within 30 days  Use of non-drug treatment for migraine in past 14 days unless have used this treatment for 14 days and plan to continue throughout study  Overuse of medications that treat pain or nausea  Migraine aura without headache  Hemiplegic or basilar migraines  Usually have vomiting with headache  Headaches that usually occur upon waking  Significant unstable medical disease  Abusing drugs or alcohol  History of a significant mental disorder  Pregnant or breast-feeding  Patients with clinically significant or unstable hepatic, respiratory, or hematologic illnesses, unstable cardiovascular disease, or symptomatic peripheral vascular disease.  Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor.  Patients with an estimated creatinine clearance of 60 mL/minute based on serum creatinine levels will be excluded.  Patient?s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2.  Patients being treated with any of the excluded medications mentioned in the protocol.  Patients with concomitant diseases such as malignancy, HIV  Participation in other trials or Previous participation in this or any other almotriptan clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 profileTimepoint: 2 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr. Nitin G Sampat
Outcome results
None listed