Efficacy and Tolerability of Zolmitriptan Nasal Spray

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Zolmitriptan; Drug: Placebo

• Registration Number: NCT00617747
• Lead Sponsor: AstraZeneca

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 (inactive drug) for 2 migraine headaches for up to 12 weeks in adult subjects with migraine headaches

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2003-06
• Study First Submitted: 2008-02-06
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-18
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-03
• Last Update Posted: 2009-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2114

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zolmitriptan	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Improvement in migraine headache pain from severe or moderate to mild or none	15 minutes after the initial dose of trial treatment

Secondary Outcome Measures

Name	Time	Method
Headache response rate	30 minutes and 1, 2 and 4 hours after dosing