None listed
Conditions
Interventions
Group 1 Type of group
single oral dose of either rizatriptan 10 mg
Group name:Group 3 Type of group
single oral placebo dose
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patient is between 18 and 65 years of age. • Patient has at least a 6-month history of migraine, with or without aura (Appendix 2). • Patient is male, or if female must be postmenopausal, surgically sterilized, or taking adequate contraceptive precautions. Any patient who is taking oral contraceptives must have received such agents for at least 2 months before entering the study. • Patient is judged to be in good health, apart from migraine, on the basis of a history and a physical examination carried out within 2 months prior to test treatment. • Patient understands the procedures is literate has the ability to complete the diary and agrees to participate in the study.
Exclusion criteria
Exclusion criteria: • Patient is either pregnant (prestudy screening using serum B-HCG test) or a nursing mother. • Patient has a history (within 1 year) or current evidence of drug or alcohol abuse. • Patient has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary hepatic, endocrine, neurological (apart from migraine), or other systemic disease. • Patient has a history or clinical evidence of cardiovascular disease, e.g., myocardial infarction, stable or unstable angina, cerebrovascular accident or transient ischemic attack. • patient has clinically significant ECG abnormality, e.g., evidence of left bundle branch block (LBBB), myocardial infarction, or ischemia. • Patient has a resting systolic blood pressure of >160 mm Hg or diastolic of >95 mm Hg at screening. • Patient has a history of any disease that in the opinion of the investigator may confound the results of the study or pose an additional risk. • Patient has received treatment with an investigational device or compound within 30 days of the study. • Patient typically suffers from 8 attacks of migraine per month, has a preponderance of mild attacks, or has a basilar or hemiplegic migraine headache. • Patient has difficulty in distinguishing his/her migraine attacks from tension or interval headaches • Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to any marketed or investigational 5HT 1B/1D receptor agonist (oral or subcutaneous), or has any contraindication to its use. • Patient is currently taking monoamine oxidase inhibitors or methysergide and is unable to tolerate withdrawal of any of these medications for the intervals required. • Patient has previousiy received rizatriptan or naratriptan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Time to relief is Defined as the first time (0.5, 1, 1.5 or 2 hours) a patient reports pain relief (= grade 1 or 0) in the 2 hours following the treatment dose. Previous experience indicates that, in general, once grade 1 or 0 is reached, a patients grade will not increase until after 2 hours. This experience justifies the validity of the time to headache relief analysis. Measure:Time to headache relief up to 2 hours following drug administration. Timepoints:p to 2 hours following drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Pain relief is defined as improvement of headache severity from grade 2 or 3 at baseline to grade O or 1. Pain free is defined as improvement of headache severity from grade 2 or 3 at baseline to grade 0. Measure:Proportion of patients reporting pain relief and pain free at 2 and 4 hours post dose Timepoints:at 2 and 4 hours post dose ; Outcome name:proportion of patients who report headache relief Measure:Averaged effect over 24 hours of the proportion of patients who report headache relief Timepoints:24 hours | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed