Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE August 30, 2013
First Posted Date  ICMJE September 30, 2013
Results First Submitted Date  ICMJE June 11, 2018
Results First Posted Date  ICMJE July 10, 2018
Last Update Posted Date November 15, 2018
Actual Study Start Date  ICMJE August 6, 2013
Actual Primary Completion Date September 25, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
Change in monthly migraine days from baseline in the last 4 weeks of the 12-week double-blind treatment phase [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with episodic migraine
Change History Complete list of historical versions of study NCT01952574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • 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%.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2013)
  • Proportion of subjects with at least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of the 12-week double-blind treatment phase [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
    To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects with at least 50% reduction from baseline in monthly migraine days
  • Change in monthly migraine attacks from baseline in the last 4 weeks of the 12-week double-blind treatment phase [ Time Frame: Completion of double-blind treatment phase at 12 weeks ]
    To evaluate the effect of AMG 334 compared to placebo as measured by reduction from baseline in monthly migraine attacks
  • Adverse events, clinical laboratory values, electrocardiogram, vital signs, anti-AMG 334 antibodies [ Time Frame: Completion of double-blind treatment phase at 12 weeks and open-label treatment phase and safety follow-up at end of study ]
    To evaluate the safety and tolerability of AMG 334
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Official Title  ICMJE A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Erenumab
    Administered once a month (QM) by subcutaneous injection
    Other Names:
    • AMG 334
    • Aimovig™
  • Drug: Placebo
    Administered once a month by subcutaneous injection
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Erenumab
  • 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.
    Intervention: Drug: Erenumab
  • 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.
    Intervention: Drug: Erenumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 11, 2014)
483
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2013)
468
Estimated Study Completion Date  ICMJE November 11, 2019
Actual Primary Completion Date September 25, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   Finland,   Germany,   Norway,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01952574
Other Study ID Numbers  ICMJE 20120178
2012-005331-90 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP