Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
NCT00632385
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Adult Trials: 18+ Years
- Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
- Eletriptan naive
- Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months
- Non-migraine headaches on average more than 6 days per month or have less than 24
hours of freedom from headache between migraine attacks
- Migraine attacks that are atypical or chronic daily headaches
- A history of migraine with prolonged aura, familial hemiplegic migraine, basilar
migraine, migrainous infarction, migraine aura without headache, migraine with acute
onset aura
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy | |||
| Official Title ICMJE | An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy | |||
| Brief Summary | To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Migraine | |||
| Intervention ICMJE | Drug: Eletriptan
40 mg oral tablet for migraine attack, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose | |||
| Study Arms ICMJE | Experimental: A
Intervention: Drug: Eletriptan | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 127 | |||
| Original Actual Enrollment ICMJE | 123 | |||
| Actual Study Completion Date ICMJE | August 2003 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00632385 | |||
| Other Study ID Numbers ICMJE | A1601092 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||