Trial record 12 of 507 for:
Migraine
Zolmitriptan Nasal Spray Versus Eletriptan in the Acute Treatment of Migraine
This study has been completed.
Sponsor:
California Medical Clinic for Headache
Information provided by:
California Medical Clinic for Headache
ClinicalTrials.gov Identifier:
NCT01276977
First received: January 11, 2011
Last updated: January 13, 2011
Last verified: January 2011
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Purpose
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 | Intervention |
|---|---|
|
Acute Migraine Migraine Headache Headache Disorders |
Drug: Zolmitriptan 5 mg Nasal Spray Drug: Eletriptan 40 mg tablet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Zolmitriptan Nasal Spray VS Eletriptan in the Acute Treatment of Migraine |
Resource links provided by NLM:
Further study details as provided by California Medical Clinic for Headache:
Primary Outcome Measures:
- Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 30 minutes post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction of migraine headache pain from mild, moderate or severe to pain free. [ Time Frame: 15 minutes post-dose ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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| Ages Eligible for Study: | 15 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276977
Locations
| United States, California | |
| California Medical Clinic for Headache | |
| Santa Monica, California, United States, 90404 | |
Sponsors and Collaborators
California Medical Clinic for Headache
Investigators
| Principal Investigator: | David B Kudrow, MD | California Medical Clinic for Headache |
More Information
No publications provided
| Responsible Party: | David Kudrow, M.D., California Medical Clinic for Headache |
| ClinicalTrials.gov Identifier: | NCT01276977 History of Changes |
| Other Study ID Numbers: | IRUSZOLM0028 |
| Study First Received: | January 11, 2011 |
| Last Updated: | January 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by California Medical Clinic for Headache:
|
Migraine Acute Migraine Headache |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Brain Diseases Central Nervous System Diseases Zolmitriptan Eletriptan |
Oxazolidinones Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Infective Agents Therapeutic Uses Protein Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013