- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01276977
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Santa Monica, California, United States, 90404
- California Medical Clinic for Headache
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zolmitriptan 5 mg nasal spray
|
Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
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Active Comparator: Eletriptan 40 mg Tablet
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Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Time Frame: 30 minutes post-dose
|
30 minutes post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of migraine headache pain from mild, moderate or severe to pain free.
Time Frame: 15 minutes post-dose
|
15 minutes post-dose
|
Collaborators and Investigators
Investigators
- Principal Investigator: David B Kudrow, MD, California Medical Clinic for Headache
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Migraine Disorders
- Headache
- Headache Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Serotonin Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Eletriptan
- Zolmitriptan
Other Study ID Numbers
- IRUSZOLM0028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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