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Evaluate Efficacy & Safety of Eptinezumab Administered Intravenously in Subjects Experiencing Acute Attack of Migraine

2019-11-11 17:50:34 | BioPortfolio

Summary

This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those patients who are candidates for preventive therapy. Subjects will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.

Description

The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in subjects experiencing an acute attack of migraine.

Study Design

Conditions

Migraine

Intervention

Eptinezumab, Placebo

Status

Not yet recruiting

Source

Alder Biopharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-11T17:50:34-0500

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Medical and Biotech [MESH] Definitions

A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Serotonin antagonist used against MIGRAINE DISORDERS and vascular headaches.

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