Zomig - Treatment of Acute Migraine Headache in Adolescents (TEENZ)

April 18, 2016 updated by: AstraZeneca

A Multicenter, Double-blind, Randomized, Placebo-controlled, 4-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5-, 2.5- and 5-mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents

The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age 12-17 years) with migraine headaches feel better. This will be done by comparing 3 different doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1653

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Mikkeli, Finland
        • Research Site
      • Turku, Finland
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nagykanizsa, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Sopron, Hungary
        • Research Site
      • Szekszárd, Hungary
        • Research Site
  • Latvia
      • Riga, Latvia
        • Research Site
      • Valmiera, Latvia
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Elblag, Poland
        • Research Site
      • Gdansk, Poland
        • Research Site
      • Kielce, Poland
        • Research Site
      • Olsztyn, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
  • Slovakia
      • Dolny Kubin, Slovakia
        • Research Site
      • Nitra, Slovakia
        • Research Site
      • Zvolen, Slovakia
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Research Site
    • California
      • Fresno, California, United States
        • Research Site
      • Fullerton, California, United States
        • Research Site
      • Newport Beach, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
    • Colorado
      • Centennial, Colorado, United States
        • Research Site
      • Colorado Springs, Colorado, United States
        • Research Site
      • Thornton, Colorado, United States
        • Research Site
    • Connecticut
      • Fairfield, Connecticut, United States
        • Research Site
    • Florida
      • Boca Raton, Florida, United States
        • Research Site
      • Hallandale Beach, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Miami Lakes, Florida, United States
        • Research Site
      • North Palm Beach, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Kentucky
      • Owensboro, Kentucky, United States
        • Research Site
    • Massachusetts
      • Worcester, Massachusetts, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
    • Minnesota
      • Plymouth, Minnesota, United States
        • Research Site
    • Mississippi
      • Ocean Springs, Mississippi, United States
        • Research Site
      • Olive Branch, Mississippi, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • Springfield, Missouri, United States
        • Research Site
      • St Louis, Missouri, United States
        • Research Site
    • New York
      • Bronx, New York, United States
        • Research Site
    • North Carolina
      • Cary, North Carolina, United States
        • Research Site
      • Hickory, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Akron, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Toledo, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Indiana, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site
      • Spring, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
      • South Jordan, Utah, United States
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Research Site
      • Norfolk, Virginia, United States
        • Research Site
    • Wisconsin
      • Middleton, Wisconsin, United States
        • Research Site

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

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of written informed consent by parent or legal guardian, and written assent provided by patient prior to any study specific procedures.
  • Established diagnosis of migraine.
  • History of a minimum of 2 migraine attacks (moderately or severely disabling)per month.

Exclusion Criteria:

  • Any medical condition that may put the patient at increased risk with exposure to zolmitriptan or that may interfere with the safety or efficacy assessments.
  • A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache.
  • Have had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug.

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Placebo
Drug: Placebo
Placebo nasal spray
EXPERIMENTAL: 2
ZOMIG 0.5 mg
Drug: Zolmitriptan
0.5 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
Drug: Zolmitriptan
2.5 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
Drug: Zolmitriptan
5.0 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
EXPERIMENTAL: 3
ZOMIG 2.5 mg
Drug: Zolmitriptan
0.5 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
Drug: Zolmitriptan
2.5 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
Drug: Zolmitriptan
5.0 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
EXPERIMENTAL: 4
ZOMIG 5.0 mg
Drug: Zolmitriptan
0.5 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
Drug: Zolmitriptan
2.5 mg nasal spray
Other Names:
  • Zomig® Nasal Spray
Drug: Zolmitriptan
5.0 mg nasal spray
Other Names:
  • Zomig® Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain-free Status at 2 Hours Post-treatment
Time Frame: 2 hours post-treatment.
2 hours post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-free Status at 24 Hours Post-treatment
Time Frame: 24 hours post-treatment
24 hours post-treatment
Headache Response at 2 Hours Post-treatment
Time Frame: 2 hours post-treatment
Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
2 hours post-treatment
Headache Response at 24 Hours Post-treatment
Time Frame: 24 hours post-treatment
Headache response is a binary response variable derived from the headache intensities recorded in the patient diary. Headache response is defined as a reduction in headache pain intensity from severe or moderate to mild or none with no use of rescue medication prior to the assessment.
24 hours post-treatment
Sustained Headache Response at 2 Hours
Time Frame: Up to 2 hours post-treatment
Sustained headache response at 2 hours is a binary response variable derived from the headache intensities recorded in the patient diary. Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none a 1 hr. which is then maintained (without a return to moderate or severe pain) at 2 hrs. with no use of rescue medication prior to the 2 hr. assessment.
Up to 2 hours post-treatment
Use of Rescue Medication During the First 24 Hours After Treatment
Time Frame: 24 hours post-treatment.
24 hours post-treatment.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Rohini Chitra, AZ Pharmaceuticals, US
  • Principal Investigator: Paul Winner, Children's Hospital of The King's Daughters

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2010

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

September 28, 2010

First Posted (ESTIMATE)

September 29, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1220C00001

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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