Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Sponsor

California Medical Clinic for Headache (Other)

Overall Status

Completed

CT.gov ID

NCT01276977

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Migraine Migraine Headache Headache Disorders	Drug: Zolmitriptan 5 mg Nasal Spray Drug: Eletriptan 40 mg tablet	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zolmitriptan 5 mg nasal spray	Drug: Zolmitriptan 5 mg Nasal Spray Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan. Drug: Eletriptan 40 mg tablet Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
Active Comparator: Eletriptan 40 mg Tablet	Drug: Zolmitriptan 5 mg Nasal Spray Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan. Drug: Eletriptan 40 mg tablet Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Arm

Intervention/Treatment

Experimental: Zolmitriptan 5 mg nasal spray

Drug: Zolmitriptan 5 mg Nasal Spray

Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.

Drug: Eletriptan 40 mg tablet

Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Active Comparator: Eletriptan 40 mg Tablet

Drug: Zolmitriptan 5 mg Nasal Spray

Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.

Drug: Eletriptan 40 mg tablet

Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Outcome Measures

Primary Outcome Measures

Reduction of migraine headache pain from mild, moderate or severe to pain free. [30 minutes post-dose]

Secondary Outcome Measures

Reduction of migraine headache pain from mild, moderate or severe to pain free. [15 minutes post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.