Zomig - Treatment of Acute Migraine Headache in Adolescents

Migraine Headache Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211145
• Other study ID #: D1220C00001
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: January 26, 2015
• Start date: September 2010
• Est. completion date: October 2013

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1653
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• Placebo
Placebo nasal spray
• Zolmitriptan
0.5 mg nasal spray
• Zolmitriptan
2.5 mg nasal spray
• Zolmitriptan
5.0 mg nasal spray

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Estonia,  Finland,  Hungary,  Latvia,  Poland,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-free Status at 2 Hours Post-treatment		2 hours post-treatment.	No
Secondary	Pain-free Status at 24 Hours Post-treatment		24 hours post-treatment	No
Secondary	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.	2 hours post-treatment	No
Secondary	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.	24 hours post-treatment	No
Secondary	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.	Up to 2 hours post-treatment	No
Secondary	Use of Rescue Medication During the First 24 Hours After Treatment		24 hours post-treatment.	No

External Links

•   D1220C00001 Clinical Study Report Synopsis