Zomig - Treatment of Acute Migraine Headache in Adolescents

Phase 4

Completed

• Conditions: Migraine Headache
• Interventions: Drug: Placebo; Drug: Zolmitriptan

• Registration Number: NCT01211145
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-10-21
• Results First Submitted QC: 2014-10-21
• Results First Posted: 2014-10-24
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1653

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	Zolmitriptan	ZOMIG 0.5 mg
3	Zolmitriptan	ZOMIG 2.5 mg
4	Zolmitriptan	ZOMIG 5.0 mg

Primary Outcome Measures

Name	Time	Method
Pain-free Status at 2 Hours Post-treatment	2 hours post-treatment.

Secondary Outcome Measures

Name	Time	Method
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 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	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	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.
Use of Rescue Medication During the First 24 Hours After Treatment	24 hours post-treatment.

Trial Locations

Locations (1)

Research Site; 🇸🇰 Zvolen, Slovakia