Migraine With or Without Aura Clinical Trial
Official title:
A Multicenter Double-blind, Randomized Placebo Controlled, Parallel Group, Study of the Efficacy and Safety of Oral Eletriptan in Subjects With Acute Migraine
| NCT number | NCT01978496 |
| Other study ID # | A160-102 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | July 1996 |
| Est. completion date | December 1997 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To confirm the efficacy of three dose levels of oral eletriptan relative to placebo in relieving symptoms of acute migraine and to further explore the dose response relationship of eletriptan.
| Status | Completed |
| Enrollment | 1334 |
| Est. completion date | December 1997 |
| Est. primary completion date | December 1997 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 78 Years |
| Eligibility | Inclusion Criteria: - History of at least one typical attack of migraine with or without aura every 6 weeks, as defined by the International Headache Society (IHS) criteria. - Capable of taking study medication as outpatients and recording its effects. Exclusion Criteria: - Pregnant or breast-feeding women - Migraine subjects who also suffered from concomitant frequent (non-migraine) headache, defined as more than six headaches per month on average - Migraine attacks that were thought to be atypical and had consistently failed to respond to medical therapy. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Headache responder rate at two hours after the first dose for the first attack. | A headache response was defined as a subject having improvement in headache severity from grade 2 or 3 at baseline to 0 or 1 at two hours post-dose. | 2 hours | |
| Secondary | Pain free responder rate at two hours after the first dose for the first attack. | Pain free response was defined as improvement from grade 2 or 3 at baseline to grade 0 at two hours post-dose. | 2 hours |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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