Efficacy and Tolerability of Zolmitriptan Nasal Spray

NCT ID: NCT00617747

Last Updated: 2009-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2003-06-30

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

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Group Type: EXPERIMENTAL

Zolmitriptan

Intervention Type: DRUG

5mg Nasal Spray

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Zolmitriptan

5mg Nasal Spray

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Zomig

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Other Identifiers

D1221L00001

Identifier Type: -

Identifier Source: secondary_id

311CUS/0022

Identifier Type: -

Identifier Source: org_study_id