NCT00637286

Brief Summary

The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

April 6, 2009

Status Verified

April 1, 2009

First QC Date

February 8, 2008

Last Update Submit

April 3, 2009

Conditions

Migraine

Keywords

ZolmitriptanZOMIGmigraineheadache responseheadacheheadache painMIDASHCPC

Outcome Measures

Primary Outcomes (1)

  • Change in Migraine Disability Assessment questionnaire (MIDAS) score

    Twice within 28 weeks

Secondary Outcomes (1)

  • Explore patients assessment of value of zolmitriptan

    Maximum of 3 times between 1 - 28 weeks

Interventions

ZolmitriptanDRUG

5mg Nasal Spray

Also known as: Zomig

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have an established diagnose of migraine as with an age at onset of less than 50 years
  • Have experienced an average of at least 1 migraine headache per month in the previous three months
  • Be able to differentiate between migraine and non-migraine headaches

You may not qualify if:

  • Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study.
  • History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache
  • History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

zolmitriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2008

First Posted

March 17, 2008

Study Start

July 1, 2004

Study Completion

May 1, 2005

Last Updated

April 6, 2009

Record last verified: 2009-04