Official Title: “A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Trial to Evaluate Early Efficacy and Tolerability of Zolmitriptan (ZOMIG) Nasal Spray in the Acute Treatment of Adult Subjects With Migraine.”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2003

Intervention(s) in this Clinical Trial

• Drug: Zolmitriptan
  • 5mg Nasal Spray
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Improvement in migraine headache pain from severe or moderate to mild or none
  • Time Frame: 15 minutes after the initial dose of trial treatment
    Safety Issue?: No

Secondary Measures

• Headache response rate
  • Time Frame: 30 minutes and 1, 2 and 4 hours after dosing
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00617747

Study ID Number: 311CUS/0022

ClinicalTrials.gov Identifier: NCT00617747

Health Authority: United States: Food and Drug Administration