None listed
Conditions
Interventions
Test drug will be given in three treatment groups as follows: (A) one rizatriptan 10 mg compressed tablet plus one placebo tablet matching zolmitriptan 2.5 mg.
Group name:ARM C Type of group
(C) one placebo tablet matching rizatriptan 10 mg and 1 placebo tablet matching zolmitriptan 2.5 mg.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria a. Patient is between 18 and 65 years of age. b. Patient has at least a 6-month history of migraine, with or without aura (Appendix 2). c. 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. d. 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. NOTE: For patients at risk of underlying coronary artery disease (CAD) (e.g., postmenopausal women, males over 40 years of age) and patients with risk factors for occult CAD (e.g., hypertension, hypercholesterolemia, diabetes, smokers, strong family history), the investigator should consider additional cardiovascular assessment. Such assessment should be conducted only after the patient has met all other inclusion and exclusion criteria, and with the concurrence of the clinical monitor. e. Patient understands the procedures, is literate, has the ability to complete the diary, and agrees to participate in the study.
Exclusion criteria
Exclusion criteria: a. Patient is either pregnant (prestudy screening using serum B-HCG test) or a nursing mother. b. Patient has a history (within 1 year) or current evidence of drug or alcohol abuse. c. Patient has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, hepatic, endocrine, neurological (apart from migraine), or other systemic disease. d. Patient has a history or clinical evidence of cardiovascular disease, e.g., myocardial infarction, stable or unstable angina, cerebrovascular accident or transient ischemic attack. e. Patient has clinically significant ECG abnormality, e.g., evidence of left bundle branch block (LBBB), myocardial infarction. f. Patient has a resting systolic blood pressure of >160 mm Hg or diastolic of >95 mm Hg at screening. g. 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. h. Patient has received treatment with an investigational device or confound within 30 days of the study. i. Patient typically suffers from 8 attacks of migraine per month, has a preponderance of mild attacks, or has basilar or hemiplegic migraine headaches. j. Patient has difiicuity in distinguishing his/her migraine attacks from tension or interval headaches. k. 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. l. Patient is currently taking monoamine oxidase inhibitors or methysergide and is unable to tolerate withdrawal of any of these medications for the intervals required. (See Section E.2.b. for appropriate withdrawal periods.)
Countries
Peru
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed