Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan
NCT01989936
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- Male and female subjects age ≥ 18 years who met the International Headache Society (IHS) diagnostic criteria for migraine, with or without aura, and could reasonably expect to suffer at least one acute attack of migraine every 6 weeks.
- Subjects required to have discontinued therapy with oral sumatriptan at least 2 weeks, but not longer than 2 years, prior to the screening visit.
- Female subjects required to be adequately protected against pregnancy.
- pregnancy or breastfeeding, known coronary artery disease, significant arrhythmias,
heart failure, significant ECG abnormalities, and uncontrolled hypertension.
- Any significant systemic, organ, neurological, endocrine, metabolic, and psychological
disorders reported by the patient or discovered during the physical examination
- Subjects considered to have atypical migraine such as frequent attacks, prolonged aura
or any migraine that was considered atypical.
- Subjects who, during the course of the trial, required treatment with sumatriptan or
any other 5-HT1B/1D agonist in addition to study medication.
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Descriptive Information | ||||
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Brief Title ICMJE | Eletriptan for the Treatment of Migraine in Patients With Previous Poor Response or Tolerance to Oral Sumatriptan | |||
Official Title ICMJE | A Multicenter, Double - Blind, Randomized, Placebo - Controlled Parallel Group Study of the Efficacy and Safety of Oral Eletriptan (40 and 80mg) Given for the Treatment of Acute Migraine in Subjects Discontinued From Oral Sumatriptan | |||
Brief Summary | To determine the tolerability and efficacy of eletriptan in patients who had discontinued oral sumatriptan due to lack of efficacy or intolerable adverse events (AEs) during previous clinical treatment (not a controlled trial). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Migraine With or Without Aura | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 446 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | September 2000 | |||
Actual Primary Completion Date | September 2000 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 68 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 | Denmark, Finland, Netherlands, Norway, Sweden | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01989936 | |||
Other Study ID Numbers ICMJE | A1601006 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | November 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |