Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
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ClinicalTrials.gov Identifier: NCT01276977 |
Recruitment Status :
Completed
First Posted : January 14, 2011
Last Update Posted : January 14, 2011
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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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | April 2008 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |

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 |
- Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 30 minutes post-dose ]
- Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 15 minutes post-dose ]

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Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276977
United States, California | |
California Medical Clinic for Headache | |
Santa Monica, California, United States, 90404 |
Principal Investigator: | David B Kudrow, MD | California Medical Clinic for Headache |
Responsible Party: | David Kudrow, M.D., California Medical Clinic for Headache |
ClinicalTrials.gov Identifier: | NCT01276977 |
Other Study ID Numbers: |
IRUSZOLM0028 |
First Posted: | January 14, 2011 Key Record Dates |
Last Update Posted: | January 14, 2011 |
Last Verified: | January 2011 |
Migraine Acute Migraine Headache |
Migraine Disorders Headache Disorders Headache Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations |
Zolmitriptan Eletriptan Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |