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Completed

NCT Number: NCT01723514

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

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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;

Treatment and study plan

Erenumab

Drug

Administered by subcutaneous injection once a month

Other names: AMG-334, Aimovig™

Placebo

Drug

Administered by subcutaneous injection once a month

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.

    Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.

    A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:

    • fatal
    • life-threatening (places the subject at immediate risk of death)
    • requires in-patient hospitalization or prolongation of existing hospitalization
    • results in persistent or significant disability/incapacity
    • congenital anomaly/birth defect
    • other medically important serious event.

  2. Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)

    The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.

  3. Number of Participants Who Developed Anti-erenumab Antibodies

    Time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)

    Participants who had a negative or no result at baseline and were antibody positive postbaseline.

    Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of Erenumab

    Time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)

    Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).

  2. Time to Maximum Observed Concentration (Tmax) of Erenumab

    Time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)

    Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).

  3. Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)

    Time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)

    Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).

  4. Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)

    Time frame: Day 57 (assessed from predose to day 225))

    Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).

  5. Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow

    Time frame: Baseline, Days 8, 57, 85, 113, 169 and 197

    Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.

    Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.

    According to the protocol, not all cohorts had dermal blood flow measurements at all time points.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and in Migraine Patients

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2012
Registry last updated
Jan 18, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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