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Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

This study is currently recruiting participants.
Verified November 2017 by Amgen
Sponsor:
ClinicalTrials.gov Identifier:
NCT03238781
First Posted: August 3, 2017
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

Condition Intervention Phase
Chronic Migraine or Episodic Migraine Drug: Placebo Drug: AMG 301 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Change from the baseline period in monthly migraine days. The monthly migraine days will be calculated using the migraine days over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.


Secondary Outcome Measures:
  • At least a 50% reduction from the baseline period in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment period [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the proportion of subject with at least 50% reduction from the baseline period in monthly migraine days

  • Change from the baseline period in monthly acute migraine-specific medication days in the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly acute migraine-specific medication treatment days.

  • Change from the baseline period in mean physical impairment domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly physical impairment domain score as measured by the Migraine Physical Function Impact Diary (MPFID).

  • Change from the baseline period in mean impact on everyday activities domain scores as measured by the MPFID over the last 4 weeks of the 12-week double-blind treatment period. [ Time Frame: Last 4 weeks ]
    To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly impact on everyday activities domain score as measured by the MPFID.


Estimated Enrollment: 335
Actual Study Start Date: September 6, 2017
Estimated Study Completion Date: December 18, 2018
Estimated Primary Completion Date: August 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
AMG 301 Placebo Comparator
Drug: Placebo
Placebo Comparator
Experimental: AMG 301 High
High dose of AMG 301 Investigational Product
Drug: AMG 301
Investigational Product
Experimental: AMG 301 Low
Low dose of AMG 301 Investigational Product
Drug: AMG 301
Investigational Product

Detailed Description:
A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
  • Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
  • History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or patient self-report.
  • Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
  • Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy as determined by the investigator, after an adequate therapeutic trial at a dose that is used in the prevention of migraine.
  • Must meet 1 of the following acute migraine-specific treatment criteria:

    1. currently taking triptans or ergotamines as acute migraine treatment (within the last month)
    2. had previously responded to triptans or ergotamines but had to discontinue due to intolerance
    3. unable to take triptans or ergotamines as acute migraine treatments due to contraindications

Exclusion Criteria:

  • Older than 50 years of age at migraine onset.
  • History of cluster headache, hemiplegic migraine headache
  • Unable to differentiate migraine from other headaches
  • Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period
  • Currently diagnosed with chronic pain syndromes
  • History of major psychiatric disorder, or current evidence of depression
  • History of seizure disorder or other significant neurological conditions other than migraine.
  • Malignancy within the 5 years before screening, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ.
  • History of HIV, hepatic disease, diabetes mellitus, or impaired glucose metabolism
  • No therapeutic response with >3 medication categories for prophylactic treatment of migraine after adequate therapeutic trial
  • Used a prohibited medication, device or procedure before the start of the baseline period
  • Currently receiving treatment in another investigation device or drug study, or less than 90 days before screening since ending treatment on another investigational device or drug study.
  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): NCT03238781


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

  Show 46 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03238781     History of Changes
Other Study ID Numbers: 20150308
2017-000630-57 ( EudraCT Number )
First Submitted: August 1, 2017
First Posted: August 3, 2017
Last Update Posted: November 24, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Migraine
Headache
Prevention
Prophylaxis

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