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A Phase 2 Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

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ClinicalTrials.gov Identifier: NCT01952574
Recruitment Status : Active, not recruiting
First Posted : September 30, 2013
Results First Posted : July 10, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
A phase 2 study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Erenumab Drug: Placebo Phase 2

Detailed Description:

The study is composed of an initial screening phase (up to 3 weeks), a 4-week baseline phase, a 12-week double-blind treatment phase, an open-label treatment phase for up to 256 weeks, and an 8-week safety follow-up (12 weeks after the last dose of investigational product). After implementation of Protocol Amendment 3, participants will increase open-label erenumab to 140 mg monthly and will have a 12-week safety follow-up (16 weeks after the last dose of investigational product).

This study is currently ongoing, with 225 participants continuing in the open-label extension phase. An analysis of the double-blind phase of the study was performed with a data cutoff date of 25 September 2014.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
Actual Study Start Date : August 6, 2013
Actual Primary Completion Date : September 25, 2014
Estimated Study Completion Date : November 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Drug: Placebo
Administered once a month by subcutaneous injection

Experimental: Erenumab 7 mg QM
Participants received erenumab 7 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Drug: Erenumab
Administered once a month (QM) by subcutaneous injection
Other Names:
  • AMG 334
  • Aimovig™

Experimental: Erenumab 21 mg QM
Participants received erenumab 21 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Drug: Erenumab
Administered once a month (QM) by subcutaneous injection
Other Names:
  • AMG 334
  • Aimovig™

Experimental: Erenumab 70 mg QM
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
Drug: Erenumab
Administered once a month (QM) by subcutaneous injection
Other Names:
  • AMG 334
  • Aimovig™




Primary Outcome Measures :
  1. Change From Baseline in Monthly Migraine Days at Week 12 [ Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase ]
    A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.


Secondary Outcome Measures :
  1. Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12 [ Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase ]
    A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.

  2. Change From Baseline in Monthly Migraine Attacks at Week 12 [ Time Frame: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase ]

    A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack.

    The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase.




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:

  • History of migraine for more than12 months prior to screening
  • Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase
  • Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase
  • Demonstrated at least 80% compliance with the eDiary during baseline phase

Exclusion Criteria:

  • Older than 50 years of age at migraine onset
  • History of cluster headache or basilar or hemiplegic migraine headache
  • Unable to differentiate migraine from other headaches
  • No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:

    • Category 1: Divalproex sodium, sodium valproate
    • Category 2: Topiramate
    • Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)
    • Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
    • Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran
    • Category 6: Flunarizine, verapamil
    • Category 7: Lisinopril, candesartan
    • Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)
  • Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening

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): NCT01952574


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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01952574     History of Changes
Other Study ID Numbers: 20120178
2012-005331-90 ( EudraCT Number )
First Posted: September 30, 2013    Key Record Dates
Results First Posted: July 10, 2018
Last Update Posted: November 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Keywords provided by Amgen:
migraine, headache, prevention, prophylaxis

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors