Zomig - Treatment of Acute Migraine Headache in Adolescents (TEENZ)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Migraine Headache

Treatments: Drug: Placebo; Drug: Zolmitriptan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01211145

D1220C00001

Details and patient eligibility

About

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).

Enrollment: 1,653 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,653 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

ZOMIG 0.5 mg

Treatment:

Drug: Zolmitriptan

Drug: Zolmitriptan

Drug: Zolmitriptan

3

Experimental group

Description:

ZOMIG 2.5 mg

Treatment:

Drug: Zolmitriptan

Drug: Zolmitriptan

Drug: Zolmitriptan

4

Experimental group

Description:

ZOMIG 5.0 mg

Treatment:

Drug: Zolmitriptan

Drug: Zolmitriptan

Drug: Zolmitriptan