Back to resultsZomig - Treatment of Acute Migraine Headache in Adolescents (TEENZ)
Primary Purpose
Migraine Headache
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo
Zolmitriptan
Zolmitriptan
Zolmitriptan
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache focused on measuring Migraine, Headache, Pain, Efficacy, Adolescents
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Placebo
ZOMIG 0.5 mg
ZOMIG 2.5 mg
ZOMIG 5.0 mg
Outcomes
Primary Outcome Measures
Pain-free Status at 2 Hours Post-treatment
Secondary Outcome Measures
Pain-free Status at 24 Hours Post-treatment
Headache Response at 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.
Headache Response at 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.
Sustained Headache Response at 2 Hours
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.
Use of Rescue Medication During the First 24 Hours After Treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01211145
Brief Title
Zomig - Treatment of Acute Migraine Headache in Adolescents
Acronym
TEENZ
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Migraine, Headache, Pain, Efficacy, Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1653 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
ZOMIG 0.5 mg
Arm Title
3
Arm Type
Experimental
Arm Description
ZOMIG 2.5 mg
Arm Title
4
Arm Type
Experimental
Arm Description
ZOMIG 5.0 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nasal spray
Intervention Type
Drug
Intervention Name(s)
Zolmitriptan
Other Intervention Name(s)
Zomig® Nasal Spray
Intervention Description
0.5 mg nasal spray
Intervention Type
Drug
Intervention Name(s)
Zolmitriptan
Other Intervention Name(s)
Zomig® Nasal Spray
Intervention Description
2.5 mg nasal spray
Intervention Type
Drug
Intervention Name(s)
Zolmitriptan
Other Intervention Name(s)
Zomig® Nasal Spray
Intervention Description
5.0 mg nasal spray
Primary Outcome Measure Information:
Title
Pain-free Status at 2 Hours Post-treatment
Time Frame
2 hours post-treatment.
Secondary Outcome Measure Information:
Title
Pain-free Status at 24 Hours Post-treatment
Time Frame
24 hours post-treatment
Title
Headache Response at 2 Hours Post-treatment
Description
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.
Time Frame
2 hours post-treatment
Title
Headache Response at 24 Hours Post-treatment
Description
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.
Time Frame
24 hours post-treatment
Title
Sustained Headache Response at 2 Hours
Description
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.
Time Frame
Up to 2 hours post-treatment
Title
Use of Rescue Medication During the First 24 Hours After Treatment
Time Frame
24 hours post-treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohini Chitra
Organizational Affiliation
AZ Pharmaceuticals, US
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Winner
Organizational Affiliation
Children's Hospital of The King's Daughters
Official's Role
Principal Investigator
Facility Information:
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Research Site
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Phoenix
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Arizona
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United States
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Fresno
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California
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United States
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Fullerton
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California
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United States
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Newport Beach
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California
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United States
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Sacramento
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California
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United States
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San Diego
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California
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United States
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San Francisco
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California
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United States
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Centennial
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Colorado
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United States
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Colorado Springs
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Colorado
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United States
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Thornton
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Colorado
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United States
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Fairfield
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Connecticut
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United States
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Boca Raton
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United States
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Hallandale Beach
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Florida
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United States
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Miami Lakes
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Florida
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United States
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Miami
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Florida
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United States
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North Palm Beach
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Orlando
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Tampa
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West Palm Beach
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Owensboro
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Kentucky
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Worcester
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Ann Arbor
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Plymouth
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Ocean Springs
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Olive Branch
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Columbia
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Springfield
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St Louis
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Missouri
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Bronx
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New York
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Cary
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North Carolina
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Hickory
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Raleigh
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Akron
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Cleveland
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Toledo
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Oklahoma City
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Indiana
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Jackson
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Nashville
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San Antonio
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Spring
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Salt Lake City
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South Jordan
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Charlottesville
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Norfolk
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Virginia
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Middleton
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Wisconsin
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Tallinn
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Estonia
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Tartu
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Estonia
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Helsinki
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Finland
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Mikkeli
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Finland
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Turku
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Finland
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyula
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Hungary
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Miskolc
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Hungary
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Nagykanizsa
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Hungary
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Nyíregyháza
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Hungary
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Pecs
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Hungary
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Sopron
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Hungary
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Szekszárd
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Hungary
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Riga
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Latvia
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Valmiera
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Latvia
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Gdansk
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Poland
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Kielce
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Poland
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Olsztyn
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Poland
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Poznan
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Poland
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Belgrade
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Serbia
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Novi Sad
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Serbia
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Dolny Kubin
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Slovakia
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Nitra
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Slovakia
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Zvolen
Country
Slovakia
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1740&filename=D1220C00001_CSR_Synopsis.pdf
Description
D1220C00001 Clinical Study Report Synopsis
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1740&filename=D1220C00001%20Revised%20CSP%203%20No%20Futility_Redacted.pdf
Description
D1220C00001 Revised CSP 3 Redacted
Learn more about this trial
Zomig - Treatment of Acute Migraine Headache in Adolescents
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