Efficacy and Tolerability of Zolmitriptan Nasal Spray

Migraine Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617747
• Other study ID #: 311CUS/0022
• Secondary ID: D1221L00001
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2008
• Last updated: April 3, 2009
• Start date: September 2002
• Est. completion date: June 2003

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2114
• Est. completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Zolmitriptan
5mg Nasal Spray
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in migraine headache pain from severe or moderate to mild or none		15 minutes after the initial dose of trial treatment	No
Secondary	Headache response rate		30 minutes and 1, 2 and 4 hours after dosing	No