Clinical trial NCT01211145: Zomig - Treatment of Acute Migraine Headache in Adolescents
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Headache
Keywords: Migraine
Headache
Pain
Efficacy
Adolescents
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 1653
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Pain-free Status at 2 Hours Post-treatment
timeFrame: 2 hours post-treatment.
Secondary outcomes:
measure: Pain-free Status at 24 Hours Post-treatment
timeFrame: 24 hours post-treatment
measure: Headache Response at 2 Hours Post-treatment
timeFrame: 2 hours post-treatment
measure: Headache Response at 24 Hours Post-treatment
timeFrame: 24 hours post-treatment
measure: Sustained Headache Response at 2 Hours
timeFrame: Up to 2 hours post-treatment
measure: Use of Rescue Medication During the First 24 Hours After Treatment
timeFrame: 24 hours post-treatment.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Fresno
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Centennial
country: United States
facility: Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Thornton
country: United States
facility: Research Site
state: Colorado
city: Fairfield
country: United States
facility: Research Site
state: Connecticut
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: North Palm Beach
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: Plymouth
country: United States
facility: Research Site
state: Minnesota
city: Ocean Springs
country: United States
facility: Research Site
state: Mississippi
city: Olive Branch
country: United States
facility: Research Site
state: Mississippi
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Springfield
country: United States
facility: Research Site
state: Missouri
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: Bronx
country: United States
facility: Research Site
state: New York
city: Cary
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Indiana
country: United States
facility: Research Site
state: Pennsylvania
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Spring
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: South Jordan
country: United States
facility: Research Site
state: Utah
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Middleton
country: United States
facility: Research Site
state: Wisconsin
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Nagykanizsa
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Szekszárd
country: Hungary
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Olsztyn
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Dolny Kubin
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Zvolen
country: Slovakia
facility: Research Site
Study officials:
affiliation: AZ Pharmaceuticals, US
name: Rohini Chitra
role: STUDY_DIRECTOR
affiliation: Children's Hospital of The King's Daughters
name: Paul Winner
role: PRINCIPAL_INVESTIGATOR
References: