Rizatriptan in Acute Treatment of Migraine in Patients With Unilateral Trigeminal-autonomic Symptoms.

This is an interventional treatment trial for Migraine focused on measuring migraine, rizatriptan, unilateral trigeminal autonomic symptoms, Migraine with or without aura Read More

Inclusion Criteria:

Male or female ≥18 years of age at screening. History of migraine with or without aura > 1 year with ≥1 and ≤8 moderate or Severe migraine attacks per month in the 2 months prior to screening that typically last longer than 2 hours.During the migraine attack (if untreated) patient has every time at least 1 of the following symptoms due to the activation of the trigeminal-autonomic reflex (UAs): unilateral conjunctival injection and/or lacrimation and/or nasal congestion/rhinorrhea and/or ptosis and/or eyelid oedema and/or forehead/facial sweating. A patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control within the projected duration of the study (intrauterine device (IUD),diaphragm with spermicide,contraceptive sponge,condoms,vasectomy.Health condition in the opinion of the investigator based on screening assessment including medical history,physical examination,and laboratory testing carried out within ~2 months prior to study treatment.Patient agrees to participate by giving written informed consent and able to complete the study questionnaire(s)and paper diary.

Exclusion Criteria:

Patient is pregnant or breast-feeding, or expecting to conceive within the projected duration of the study.Patient has difficulty distinguishing his/her migraine attacks from tension or interval headaches.History of predominantly mild migraine attacks or migraines usually resolved spontaneously in less than 2 hours.Basilar or hemiplegic migraine headache.Patient has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening.Patient is taking migraine Propranolol or has discontinued it from less than 14 days.Patient is taking migraine prophylactic medication where the prescribed daily dose has changed during the 3 months prior to screening.Patient was > 50 years old at age of migraine onset. Recent history (within the past 5 years) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs.Concomitant use of propranolol, ergot derivatives, methysergide or MAO inhibitors.Hypersensitivity to any marketed 5HT1B/1D receptor agonist.History or clinical evidence of ischemic heart disease (e.g., angina pectoris of any type, history of myocardial infarction or documented silent ischemia) or symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm (including Prinzmetal's variant angina,or other significant underlying cardiovascular disease.Patient has clinical,laboratory,or ECG evidence of uncontrolled hypertension, uncontrolled diabetes, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the investigator.Patient has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression based on criteria such as DSM-IV, dementia or significant neurological disorders other than migraine.History of neoplastic disease ≤ 5 years prior to signing informed consent.Patient has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding), or has a disease that causes malabsorption. History or current evidence of any clinically significant disease that according to the investigator might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation for the full duration of the study, or pose an additional undue risk to the patient.