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Ascending Multiple-Doses of AMG 334 in Healthy Subjects and in Migraine Patients

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ClinicalTrials.gov Identifier: NCT01723514
Recruitment Status : Completed
First Posted : November 8, 2012
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary purpose of this study is to determine whether AMG 334 is safe and well tolerated in healthy subjects and migraine patients. As part of the secondary objectives, this study will be conducted to characterize the pharmacokinetic (PK) profile of AMG 334 after multiple SC doses in healthy subjects and migraine patients, as well as to characterize the effect of AMG 334 on the capsaicin induced increase in dermal blood flow after multiple SC doses in healthy subjects and migraine patients.

Condition or disease Intervention/treatment Phase
Migraine Drug: AMG 334 Drug: Placebo Phase 1

Detailed Description:
In this ascending multiple dose, double blind, placebo controlled study, a total of 40 subjects will be randomized into 5 cohorts. Approximately 24 HS will be randomized into 3 cohorts (A1, A2, and A3), and 16 migraine patients will be randomized into 2 cohorts (B1 and B2). Each subject will receive a total of 3 SC doses of AMG 334 or placebo.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2012
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: AMG 334 Treatment A
3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
Drug: AMG 334
3 dose levels of AMG 334 administered as multiple SC doses in healthy subjects and migraine patients.
Placebo Comparator: AMG 334 Treatment B
3 dose levels administered as multiple SC doses in healthy subjects and migraine patients
Drug: Placebo
3 dose levels of Placebo administered as multiple SC doses in healthy subjects and migraine patients.


Outcome Measures

Primary Outcome Measures :
  1. The number of treatment emergent adverse events per subject, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs. [ Time Frame: Up to 197 days ]
    physical and neurological examinations, vitals, clinical laboratories, ECGs


Secondary Outcome Measures :
  1. The maximum observed concentration, time to maximum concentration and the area under the serum-concentration curve after multiple doses of AMG 334. [ Time Frame: Up to 197 days ]
    Concentration time profiles for AMG 334

  2. The ratio of blood flow measure at 30 minute post capsaicin challenge to the flow measure prior to the capsaicin challenge. [ Time Frame: Up to 197 days ]
    Blood flow measure at 30 minute post dose capsaicin challenge to the blood flow measure prior to the capsaicin challenge


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

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): NCT01723514


Locations
Belgium
Research Site
Leuven, Belgium, 3000
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01723514     History of Changes
Other Study ID Numbers: 20101268
First Posted: November 8, 2012    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Amgen:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases