Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine

Migraine Headache Clinical Trial

Official title:

Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01276977
• Other study ID #: IRUSZOLM0028
• Status: Completed
• Phase: N/A
• First received: January 11, 2011
• Last updated: January 13, 2011
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: California Medical Clinic for Headache
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Migraine
• Headache
• Headache Disorders
• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• Zolmitriptan 5 mg Nasal Spray
Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
• Eletriptan 40 mg tablet
Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray

Locations

Country	Name	City	State
United States	California Medical Clinic for Headache	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
California Medical Clinic for Headache

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of migraine headache pain from mild, moderate or severe to pain free.		30 minutes post-dose	No
Secondary	Reduction of migraine headache pain from mild, moderate or severe to pain free.		15 minutes post-dose	No