To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
NCT ID: NCT02542605
Last Updated: 2019-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2015-11-11
2017-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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PACAP-38 Challenge Agent
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.
PACAP-38 Challenge Agent
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.
Placebo
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.
Placebo
Administered once on day 1 of Part B of the study by intravenous infusion.
PACAP-38 Challenge Agent
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.
Erenumab
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.
Erenumab
Administered once on day 1 of Part B of the study by intravenous infusion.
PACAP-38 Challenge Agent
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.
Interventions
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Erenumab
Administered once on day 1 of Part B of the study by intravenous infusion.
Placebo
Administered once on day 1 of Part B of the study by intravenous infusion.
PACAP-38 Challenge Agent
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* ≥ 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)
18 Years
45 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anaheim, California, United States
Research Site
Leuven, , Belgium
Research Site
Leiden, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20140207
Identifier Type: -
Identifier Source: org_study_id
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