Zomig - Treatment of Acute Migraine Headache in Adolescents

NCT01211145 | Completed Phase 4 Results

• 1 other identifier: D1220C00001
• Study Type: interventional
• Target: 1,653
• Locations: 8 countries
• Sites: 74

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).

Conditions

Migraine Headache

Keywords

Migraine; Headache; Pain; Efficacy; Adolescents

Outcome Measures

Primary Outcomes (1)

• Pain-free Status at 2 Hours Post-treatment

  2 hours post-treatment.

Secondary Outcomes (5)

• Pain-free Status at 24 Hours Post-treatment

  24 hours post-treatment

• Headache Response at 2 Hours Post-treatment

  2 hours post-treatment

• Headache Response at 24 Hours Post-treatment

  24 hours post-treatment

• Sustained Headache Response at 2 Hours

  Up to 2 hours post-treatment

• Use of Rescue Medication During the First 24 Hours After Treatment

  24 hours post-treatment.

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

2

EXPERIMENTAL

ZOMIG 0.5 mg

Drug: Zolmitriptan

3

EXPERIMENTAL

ZOMIG 2.5 mg

Drug: Zolmitriptan

4

EXPERIMENTAL

ZOMIG 5.0 mg

Drug: Zolmitriptan

Interventions

Placebo DRUG

Placebo nasal spray

1

Zolmitriptan DRUG

0.5 mg nasal spray

Also known as: Zomig® Nasal Spray

2

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (74)

Research Site

Phoenix, Arizona, United States

Location

Research Site

Fresno, California, United States

Location

Research Site

Fullerton, California, United States

Location

Research Site

Newport Beach, California, United States

Location

Research Site

Sacramento, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

San Francisco, California, United States

Location

Research Site

Centennial, Colorado, United States

Location

Research Site

Colorado Springs, Colorado, United States

Location

Research Site

Thornton, Colorado, United States

Location

Research Site

Fairfield, Connecticut, United States

Location

Research Site

Boca Raton, Florida, United States

Location

Research Site

Hallandale, Florida, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Miami Lakes, Florida, United States

Location

Research Site

North Palm Beach, Florida, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

West Palm Beach, Florida, United States

Location

Research Site

Owensboro, Kentucky, United States

Location

Research Site

Worcester, Massachusetts, United States

Location

Research Site

Ann Arbor, Michigan, United States

Location

Research Site

Plymouth, Minnesota, United States

Location

Research Site

Ocean Springs, Mississippi, United States

Location

Research Site

Olive Branch, Mississippi, United States

Location

Research Site

Columbia, Missouri, United States

Location

Research Site

Springfield, Missouri, United States

Location

Research Site

St Louis, Missouri, United States

Location

Research Site

The Bronx, New York, United States

Location

Research Site

Cary, North Carolina, United States

Location

Research Site

Hickory, North Carolina, United States

Location

Research Site

Raleigh, North Carolina, United States

Location

Research Site

Akron, Ohio, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Toledo, Ohio, United States

Location

Research Site

Oklahoma City, Oklahoma, United States

Location

Research Site

Indiana, Pennsylvania, United States

Location

Research Site

Jackson, Tennessee, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

San Antonio, Texas, United States

Location

Research Site

Spring, Texas, United States

Location

Research Site

Salt Lake City, Utah, United States

Location

Research Site

South Jordan, Utah, United States

Location

Research Site

Charlottesville, Virginia, United States

Location

Research Site

Norfolk, Virginia, United States

Location

Research Site

Middleton, Wisconsin, United States

Location

Research Site

Tallinn, Estonia

Location

Research Site

Tartu, Estonia

Location

Research Site

Helsinki, Finland

Location

Research Site

Mikkeli, Finland

Location

Research Site

Turku, Finland

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Gyula, Hungary

Location

Research Site

Miskolc, Hungary

Location

Research Site

Nagykanizsa, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Pécs, Hungary

Location

Research Site

Sopron, Hungary

Location

Research Site

Szekszárd, Hungary

Location

Research Site

Riga, Latvia

Location

Research Site

Valmiera, Latvia

Location

Research Site

Bialystok, Poland

Location

Research Site

Bydgoszcz, Poland

Location

Research Site

Elblag, Poland

Location

Research Site

Gdansk, Poland

Location

Research Site

Kielce, Poland

Location

Research Site

Olsztyn, Poland

Location

Research Site

Poznan, Poland

Location

Research Site

Belgrade, Serbia

Location

Research Site

Novi Sad, Serbia

Location

Research Site

Dolný Kubín, Slovakia

Location

Research Site

Nitra, Slovakia

Location

Research Site

Zvolen, Slovakia

Location

Related Links

• D1220C00001 Clinical Study Report Synopsis
• D1220C00001 Revised CSP 3 Redacted

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain

Interventions

zolmitriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jamie Mullen, Medical Science Director
• Organization: AstraZeneca

jamie.mullen@astrazeneca.com

781-472-5032

Study Officials

• Rohini Chitra

  AZ Pharmaceuticals, US

  STUDY DIRECTOR

• Paul Winner

  Children's Hospital of The King's Daughters

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 18, 2016
• Results First Posted: October 24, 2014

Record last verified: 2016-04

Locations

SL (3); SE (2); ES (2); LA (2); PL (7); US (46); FI (3); HU (9)