NCT00617747

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,114

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
Last Updated

April 6, 2009

Status Verified

April 1, 2009

First QC Date

February 6, 2008

Last Update Submit

April 3, 2009

Conditions

Migraine

Keywords

ZolmitriptanZOMIGmigraineheadache responseheadacheheadache pain

Outcome Measures

Primary Outcomes (1)

  • Improvement in migraine headache pain from severe or moderate to mild or none

    15 minutes after the initial dose of trial treatment

Secondary Outcomes (1)

  • Headache response rate

    30 minutes and 1, 2 and 4 hours after dosing

Study Arms (2)

1

EXPERIMENTAL
Drug: Zolmitriptan

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ZolmitriptanDRUG

5mg Nasal Spray

Also known as: Zomig
1
PlaceboDRUG
2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

September 1, 2002

Study Completion

June 1, 2003

Last Updated

April 6, 2009

Record last verified: 2009-04