Clinical trial NCT01723514: Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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;

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
measure: Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
measure: Number of Participants Who Developed Anti-erenumab Antibodies
timeFrame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Erenumab
timeFrame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
measure: Time to Maximum Observed Concentration (Tmax) of Erenumab
timeFrame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
measure: Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)
timeFrame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
measure: Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
timeFrame: Day 57 (assessed from predose to day 225))
measure: Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
timeFrame: Baseline, Days 8, 57, 85, 113, 169 and 197
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.
citation: Kudrow D, Pascual J, Winner PK, Dodick DW, Tepper SJ, Reuter U, Hong F, Klatt J, Zhang F, Cheng S, Picard H, Eisele O, Wang J, Latham JN, Mikol DD. Vascular safety of erenumab for migraine prevention. Neurology. 2020 Feb 4;94(5):e497-e510. doi: 10.1212/WNL.0000000000008743. Epub 2019 Dec 18.