Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
- Registration Number
- NCT01723514
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57. Erenumab Erenumab Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events 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.Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) 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.
Number of Participants Who Developed Anti-erenumab Antibodies 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
Name Time Method Maximum Observed Serum Concentration (Cmax) of Erenumab 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).
Time to Maximum Observed Concentration (Tmax) of Erenumab 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).
Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day) 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).
Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) Day 57 (assessed from predose to day 225)) Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow 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.
Trial Locations
- Locations (1)
Research Site
🇧🇪Leuven, Belgium