Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

California Medical Clinic for Headache

Status

Completed

Conditions

Headache Disorders

Acute Migraine

Migraine Headache

Treatments

Drug: Zolmitriptan 5 mg Nasal Spray

Drug: Eletriptan 40 mg tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT01276977

IRUSZOLM0028

Details and patient eligibility

About

The purpose of this study is to Compare the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet in the acute treatment of migraine.

To develop and evaluate a set of importance weights for a predefined set of treatment attributes for migraine suffers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

To contrast the efficacy of zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet at early time points.

To analyze the patterns of self-reported tolerability of migraine sufferers using zolmitriptan 5 mg nasal spray vs. eletriptan 40 mg tablet.

Full description

An open-label, randomized, cross-over study comparing the efficacy of zolmitriptan 5 mg nasal spray with eletriptan 40 mg tablet at early time points. Satisfaction endpoints include global assessment of preference, overall satisfaction and effectiveness as well as tolerability of both medications.

Enrollment

80 patients

Sex

All

Ages

15 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

15 to 70 years old
Migraine attacks according to the criteria proposed by the IHS
3-12 Migraine attacks per month
adequate contraception
Willing and able to give written informed consent
Willing and able to complete the entire course of the study & comply with instructions
Stable dose of preventive medication for at least 4 weeks

Exclusion criteria

Disorders listen in groups 5-11 of the IHS Classification
Subject is pregnant or lactating.
Significant medical or psychiatric disease
Subject has a history of symptoms suggestive of ischemic heart disease (angina, myocardial infarction, documented silent ischemia) or other vascular disease, including Prinzmetal angina, claudication, Wolff-Parkinson-White syndrome, or other cardiac accessory conduction pathway arrhythmia
Subject has uncontrolled hypertension.
Subject has history of basilar, ophthalmoplegic, or hemiplegic migraine or serious neurologic condition associated with headache
Subject has used monoamine oxidase A inhibitors (MAOI-As) within 2 weeks of randomization
Subject has had serious adverse event while using another 5-HT agonist, or previous serious adverse event while using zolmitriptan or hypersensitivity to zolmitriptan or eletriptan
Using CYP3A4 inhibitors listed by the FDA as contraindicated with eletriptan
Moderate/severe hepatic/renal impairment
Subject currently using cimetidine
Concomitant medication treatment with a triptan, ergotamine or methysergide.