Efficacy and Tolerability of Zolmitriptan Nasal Spray

April 3, 2009 updated by: AstraZeneca

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2114

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
EXPERIMENTAL: 1
Drug: Zolmitriptan
5mg Nasal Spray
Other Names:
  • Zomig

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in migraine headache pain from severe or moderate to mild or none
Time Frame: 15 minutes after the initial dose of trial treatment
15 minutes after the initial dose of trial treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Headache response rate
Time Frame: 30 minutes and 1, 2 and 4 hours after dosing
30 minutes and 1, 2 and 4 hours after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (ACTUAL)

June 1, 2003

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 6, 2008

First Posted (ESTIMATE)

February 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2009

Last Update Submitted That Met QC Criteria

April 3, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 311CUS/0022
  • D1221L00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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