Efficacy and Tolerability of Zolmitriptan Nasal Spray

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Migraine

Treatments

Drug: Zolmitriptan

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00617747

D1221L00001

311CUS/0022

Details and patient eligibility

About

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

Enrollment

2,114 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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