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

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ClinicalTrials.gov Identifier: NCT02542605
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: AMG 334 Drug: Placebo Drug: PACAP-38 Challenge Agent Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 11, 2015
Primary Completion Date : September 28, 2017
Study Completion Date : November 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: AMG 334 Drug: AMG 334
AMG 334 Investigational Product
Placebo Comparator: Placebo Drug: Placebo
Placebo Comparator
PACAP-38 Challenge Agent Drug: PACAP-38 Challenge Agent
PACAP-38 challenge agent


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of a migraine-like attack within 24 hours of challenge agent infusion [ Time Frame: 1 day ]
    Occurrence of a migraine-like attack within 24 hours of challenge agent infusion


Secondary Outcome Measures :
  1. Occurrence of a headache within 24 hours of challenge-agent infusion [ Time Frame: 1 day ]
    Occurrence of a headache within 24 hours of challenge-agent infusion

  2. Treatment-emergent adverse events [ Time Frame: 85 days ]
    Treatment-emergent adverse events

  3. Clinical significant changes in vital signs, ECGs, physical examinations, laboratory safety tests and neurological assessments [ Time Frame: 85 days ]
    Clinical significant changes in vital signs, ECGs, physical examinations, laboratory safety tests and neurological assessments

  4. AMG 334 PK parameters, including C1 hour and AUC0-85 [ Time Frame: 85 days ]
    AMG 334 PK parameters, including C1 hour and AUC0-85

  5. Anti-AMG 334 antibodies [ Time Frame: 85 days ]
    Anti-AMG 334 antibodies


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 IHS Classification 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:

  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542605


Locations
United States, California
Research Site
Anaheim, California, United States, 92801
Belgium
Research Site
Leuven, Belgium, 3000
Netherlands
Research Site
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02542605     History of Changes
Other Study ID Numbers: 20140207
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: November 2017

Keywords provided by Amgen:
Migraine
Headache
Migraine Headache
Headache, Migraine
Amgen

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pituitary Adenylate Cyclase-Activating Polypeptide
Growth Substances
Physiological Effects of Drugs
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action