NCT00617695

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of Zolmitriptan (Zomig) nasal spray, 5.0 mg, compared with placebo (inactive drug) for 2 migraine headaches over a 3-month period in adolescent patients (aged 12 to 17 years) with migraine headaches

Trial Health

100
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3.4 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

October 2, 2024

Status Verified

April 1, 2009

First QC Date

February 6, 2008

Last Update Submit

September 30, 2024

Conditions

Migraine

Keywords

ZolmitriptanZOMIGmigraineheadache responseheadacheheadache pain

Outcome Measures

Primary Outcomes (1)

  • Headache response and pain-free response to treatment

    15 minutes, 30 minutes, 45 minutes, 1.5 hours and 2 hours after randomized treatment

Secondary Outcomes (1)

  • Adverse Event reports

    Four times within 12 weeks

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

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents aged 12-17 years at the time of screening. Patients must not be enrolled if they will turn 18 years of age within 12 weeks after randomization.
  • An established diagnosis of migraine for at least 1 year; a minimum of 2 migraines, considered to be moderately/severely disabling, per month on average during the school year
  • A history of usual migraine duration of \>2-hours untreated for the 3 month prior to screening

You may not qualify if:

  • A history of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache or clinically significant abnormalities indicated from the medical history, physical exam etc
  • Has used monoamine oxidase inhibitor-A (MAO-A), methysergide, methylergonovine or cimetidine in the 2 weeks before randomization.
  • Evidence of ischemic heart disease, arrhythmia, accessory conduction pathway disorder as determined by central cardiologist using predetermined and agreed upon pediatric standards; Has 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
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

September 1, 2003

Study Completion

October 1, 2004

Last Updated

October 2, 2024

Record last verified: 2009-04