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

NCT01723514 | Completed Phase 1 Results

• 2 other identifiers: 201012682012-003594-26
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events

  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.

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

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

  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.

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

• Number of Participants Who Developed Anti-erenumab Antibodies

  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.

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

Secondary Outcomes (5)

• 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)

• 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)

• 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)

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

  Day 57 (assessed from predose to day 225))

• Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow

  Baseline, Days 8, 57, 85, 113, 169 and 197

Study Arms (2)

Erenumab

EXPERIMENTAL

Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.

Drug: Erenumab

Placebo

PLACEBO COMPARATOR

Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.

Drug: Placebo

Interventions

Erenumab DRUG

Administered by subcutaneous injection once a month

Also known as: AMG-334, Aimovig™

Erenumab

Placebo DRUG

Administered by subcutaneous injection once a month

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• \- 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;

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Research Site

Leuven, 3000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 28736918 BACKGROUND

• 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.

  PMID: 31852816 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: November 14, 2012
• Primary Completion: July 10, 2014
• Study Completion: July 10, 2014
• Last Updated: January 18, 2019
• Results First Posted: January 18, 2019

Record last verified: 2018-08

Locations

BE (1)