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Completed

NCT Number: NCT01859481

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

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

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine With Aura Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eeuwfeestkliniek, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female subjects in good general health, aged 18 to 65 years.
  • Subjects should meet IHS diagnostic criteria for migraine with or without aura.
  • Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion criteria

  • Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
  • Pregnant or lactating women.
  • Clinically significant electrocardiogram abnormalities at screening.

Treatment and study plan

Placebo

Drug

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.

Eletriptan HBr 40 mg

Drug

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.

Eletriptan HBr 80 mg

Drug

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.

Primary outcomes

  1. Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.

    Time frame: 24 weeks

Secondary outcomes

  1. Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose.

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
May 22, 2013
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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