To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

NCT02542605 | Completed Phase 1 Results

• 1 other identifier: 20140207
• Study Type: interventional
• Target: 35
• Locations: 3 countries
• Sites: 3

Brief Summary

Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced Migraine-like Attacks in Migraine Patients.

Conditions

Migraine

Keywords

Migraine; Headache; Migraine Headache; Headache, Migraine; Amgen

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion

  On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion. A MLA was defined as fulfilling 1 of the 2 criteria: 1. Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia. 2. Headache described as mimicking usual migraine attack treated with triptan.

  Part B randomization phase day 8 plus 24 hours.

Secondary Outcomes (21)

• Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion

  Part B randomization phase day 8 plus 24 hours.

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Part B randomization phase day 1 until EOS (up to 12 weeks).

• Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS

  Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

• Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS

  Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

• Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS

  Part B randomization phase baseline and day 1, day 8 and EOS (week 12).

Study Arms (3)

PACAP-38 Challenge Agent

OTHER

In Part A, 4 cohorts of 2 to 5 participants sequentially received an intravenous infusion of 10 picomol/kilogram/minute (pmol/kg/minute) PACAP-38 for 2.5, 5, 7.5 and 10 minutes each in order to determine the dose for Part B.

Drug: PACAP-38 Challenge Agent

Placebo

PLACEBO COMPARATOR

Participants were randomized to receive matching erenumab placebo by intravenous administration over 30 minutes on day 1. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.

Drug: Placebo; Drug: PACAP-38 Challenge Agent

Erenumab

EXPERIMENTAL

Participants were randomized to receive 140 milligrams (mg) erenumab by intravenous administration over 30 minutes on day 1 in Part B. On day 8 participants were administered the dose of PACAP-38 determined from Part A of the study (100 pmol/kg) and were followed up for 11 weeks.

Drug: Erenumab; Drug: PACAP-38 Challenge Agent

Interventions

Erenumab DRUG

Administered once on day 1 of Part B of the study by intravenous infusion.

Also known as: AMG 334, Aimovig™

Erenumab

Placebo DRUG

Administered once on day 1 of Part B of the study by intravenous infusion.

Placebo

PACAP-38 Challenge Agent DRUG

Administered by intravenous infusion during Part A of the study for dose selection for Part B. Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.

Also known as: Pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38)

Erenumab; PACAP-38 Challenge Agent; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ≥ 18 to ≤ 45 years of age upon entry into screening
• History of migraine headaches without aura for ≥ 6 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-II) (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
• Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior to screening

You may not qualify if:

• History of migraine with aura, cluster headache or hemiplegic migraine headache according to the IHS Classification ICHD-II (Headache Classification Committee of the International Headache Society, 2004) based on medical records and/or patient self-report
• ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during screening period
• Other headache disorders (except for episodic tension-type headache \<5 days/month)

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

Research Site

Anaheim, California, 92801, United States

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Leiden, 2333 CL, Netherlands

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

erenumab; Pituitary Adenylate Cyclase-Activating Polypeptide

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Neuropeptides; Proteins; Nerve Tissue Proteins; Biological Factors

Limitations and Caveats

The study was terminated early due to slow recruitment rate.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: November 11, 2015
• Primary Completion: September 28, 2017
• Study Completion: November 8, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

NL (1); BE (1); US (1)