Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-14

Study Completion Date

2014-07-10

Brief Summary

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The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy adults and migraine patients.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Erenumab

Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.

Group Type EXPERIMENTAL

Erenumab

Intervention Type DRUG

Administered by subcutaneous injection once a month

Placebo

Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered by subcutaneous injection once a month

Interventions

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Erenumab

Administered by subcutaneous injection once a month

Intervention Type DRUG

Placebo

Administered by subcutaneous injection once a month

Intervention Type DRUG

Other Intervention Names

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AMG-334 Aimovig™

Eligibility Criteria

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Inclusion Criteria

Healthy male and female subjects, as well as male or female subjects with migraines between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician;

Exclusion Criteria

\- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes