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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01723514
Recruitment Status : Completed
First Posted : November 8, 2012
Results First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Erenumab Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : November 14, 2012
Actual Primary Completion Date : July 10, 2014
Actual Study Completion Date : July 10, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Erenumab
Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.
Drug: Erenumab
Administered by subcutaneous injection once a month
Other Names:
  • AMG-334
  • Aimovig™

Placebo Comparator: Placebo
Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.
Drug: Placebo
Administered by subcutaneous injection once a month




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723514


Locations
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Belgium
Research Site
Leuven, Belgium, 3000
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01723514    
Other Study ID Numbers: 20101268
2012-003594-26 ( EudraCT Number )
First Posted: November 8, 2012    Key Record Dates
Results First Posted: January 18, 2019
Last Update Posted: January 18, 2019
Last Verified: August 2018
Keywords provided by Amgen:
Migraine
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs