A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders

0462-087

A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.

2009-06-10

2010-01-12

2010-01-12

Completed

Early phase I

109

Inclusion Criteria: * Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month * Patient generally does not respond to treatment with sumatriptan * Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study * Patient is able to complete paper diary Exclusion Criteria: * Patient is pregnant or breast feeding or excepts to become pregnant during the study * Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours * Patient has basilar or hemiplegic migraines * Patient is unable to distinguish between migraine attacks from other types of headaches * Patient has more than 15 headache-days per month * Patient was greater than 50 years old at age of migraine onset * Patient has failed to respond to 3 or more triptans * Patient has a repeated history of failing to respond to or tolerate rizatriptan * Patient uses opioids as primary migraine therapy * Patient uses daily opioids * Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease * Patient has uncontrolled hypertension * Patient has a history of neoplastic disease * Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening * Patient has a history of drug or alcohol abuse

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 109, 'type': 'ACTUAL'}}

2024-05-10