Status:
COMPLETED
Efficacy and Tolerability of Zolmitriptan Nasal Spray
Lead Sponsor:
AstraZeneca
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the effectiveness and tolerability (the ability not to experience ill effects from the study drug) of a zolmitriptan nasal spray, 5.0 mg, compared with placebo...
Eligibility Criteria
Inclusion
- Subject has an established diagnosis of migraine headache, with or without aura
- Subject has a medical history indicating the presence of migraine attacks for at least 1 year before the start of the trial or a minimum of 2 and maximum of 6 migraine attacks per month on average for 3 months preceding the study
- Subject has non migraine headaches on fewer than 6 days each month for 3 months preceding the study
Exclusion
- Subject has history of basilar, ophthalmoplegic or hemiplegic migraine or serious neurologic condition associated with headache
- Subject has used a MAOI within 2 weeks of randomisation or has been given SSRI therapy or migraine prophylactic agent within 3 months of randomisation. Subject requires treatment with propranolol or cimetidine or has had an intolerable or serious adverse event while using another triptan
- Subject has a history or symptoms suggestive of ischemic heart disease, coronary artery vasospasm or other significant underlying cardiovascular disease or clinically significant abnormalities seen on an ECG or uncontrolled hypertension
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
2114 Patients enrolled
Trial Details
Trial ID
NCT00617747
Start Date
September 1 2002
End Date
June 1 2003
Last Update
April 6 2009
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