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Completed

NCT Number: NCT01688739

Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and 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 single subcutaneous (SC) or intravenous (IV) doses in healthy participants and migraine patients as well as to characterize the effect of erenumab on the capsaicin-induced increase in dermal blood flow after single SC or IV doses in healthy participants 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

About this study

This study was a single-dose, double-blind, placebo-controlled, sequential dose escalation study in which participants were to be enrolled into 8 cohorts.

In Part 1 healthy participants were randomized in a 3:1 ratio (erenumab:placebo) into 6 cohorts: 5 cohorts received the investigational product (IP) as an SC administration and 1 cohort received it as an IV administration. In Part 2 a total of 12 migraine patients were randomized in a 1:1 ratio (erenumab:placebo) in cohort 7. An additional 8 migraine patients could have been enrolled and randomized in a 3:1 ratio in the optional cohort 8, however this cohort was not enrolled.

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 between 18 and 45 years of age, or 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 or intravenous injection

Other names: AMG 334, Aimovig™

Placebo

Drug

Administered by subcutaneous injection or intravenous injection

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From the initial dose of study drug up to 155 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 Who Developed Anti-erenumab Antibodies

    Time frame: Baseline and up to 155 days postdose

    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 Concentration (Cmax) of Erenumab

    Time frame: Predose to 155 days postdose

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

    Time frame: Predose to 155 days postdose

  3. Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab

    Time frame: Predose to 155 days postdose

  4. Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab

    Time frame: Predose to 155 days postdose

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

    Time frame: Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort).

    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

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 20, 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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