Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
Information source: California Medical Clinic for Headache
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Migraine; Migraine Headache; Headache Disorders
Intervention: Zolmitriptan 5 mg Nasal Spray (Drug); Eletriptan 40 mg tablet (Drug)
Phase: N/A
Status: Completed
Sponsored by: California Medical Clinic for Headache Official(s) and/or principal investigator(s): David B Kudrow, MD, Principal Investigator, Affiliation: California Medical Clinic for Headache
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.
Clinical Details
Official title: Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Reduction of migraine headache pain from mild, moderate or severe to pain free.
Secondary outcome: Reduction of migraine headache pain from mild, moderate or severe to pain free.
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.
Eligibility
Minimum age: 15 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
California Medical Clinic for Headache, Santa Monica, California 90404, United States
Additional Information
Starting date: April 2008
Last updated: January 13, 2011
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