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.

AstraZeneca0 sites2,114 target enrollmentSeptember 2002

ConditionsMigraine

InterventionsZolmitriptan Placebo

DrugsZolmitriptan Placebo

Overview

Phase: Phase 3
Intervention: Zolmitriptan
Conditions: Migraine
Sponsor: AstraZeneca
Enrollment: 2114
Primary Endpoint: Improvement in migraine headache pain from severe or moderate to mild or none
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2002

End Date

June 2003

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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