Migraine With or Without Aura Clinical Trial
Official title:
A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
| NCT number | NCT01986270 |
| Other study ID # | A160-104 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | December 1996 |
| Est. completion date | January 1998 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.
| Status | Completed |
| Enrollment | 1141 |
| Est. completion date | January 1998 |
| Est. primary completion date | January 1998 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS)) - Subjects capable of taking medication as outpatients, and recording the effects of such medication. Exclusion Criteria: - Pregnant or breast-feeding women - Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average. |
| 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 response at 1 hour after the first dose for the first attack. | Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose. | 1 hour | |
| Secondary | Pain-free response at 1 hour after the first dose for the first attack. | A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose. | 1 hour |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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