Efficacy and Tolerability of Zolmitriptan Nasal Spray
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Zolmitriptan (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca
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
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in migraine headache pain from severe or moderate to mild or none
Secondary outcome: Headache response rate
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: September 2002
Ending date: October 2003
Last updated: February 6, 2008
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