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Completed

NCT Number: NCT01211145

Zomig - 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).

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Key information

Conditions

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

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Tallinn, Estonia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo nasal spray

Zolmitriptan

Drug

0.5 mg nasal spray

Other names: Zomig® Nasal Spray

Primary outcomes

  1. Pain-free Status at 2 Hours Post-treatment

    Time frame: 2 hours post-treatment.

Secondary outcomes

  1. Pain-free Status at 24 Hours Post-treatment

    Time frame: 24 hours post-treatment

  2. 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.

  3. 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.

  4. 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.

  5. Use of Rescue Medication During the First 24 Hours After Treatment

    Time frame: 24 hours post-treatment.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: TEENZ

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2010
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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