NCT01859481

Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 971 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

Conditions

• Migraine Without Aura
• Migraine With Aura

Interventions

Type	Name	Description
DRUG	Placebo	All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
DRUG	Eletriptan HBr 40 mg	All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
DRUG	Eletriptan HBr 80 mg	All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.

Timeline

• Start date: 2000-03-01
• Primary completion: 2002-03-01
• Completion: 2002-03-01
• First posted: 2013-05-22
• Last updated: 2021-01-27

Locations

148 sites across 14 countries: Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Turkey (Türkiye)