A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)

May 4, 2020 updated by: Alder Biopharmaceuticals, Inc.

A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines

The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

898

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Tbilisi, Georgia, 0160
        • Research Site
      • Tbilisi, Georgia, 0179
        • Research Site
      • Tbilisi, Georgia, 0186
        • Research Site
      • Tbilisi, Georgia, 0112
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Research Site
      • Tucson, Arizona, United States, 85712
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Fresno, California, United States, 93702
        • Research Site
      • Fullerton, California, United States, 92835
        • Research Site
      • Long Beach, California, United States, 90806
        • Research Site
      • Montclair, California, United States, 91763
        • Research Site
      • Oceanside, California, United States, 92056
        • Research Site
      • Redlands, California, United States, 92374
        • Research Site
      • San Diego, California, United States, 92108
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
      • Sherman Oaks, California, United States, 91403
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Research Site
      • Fort Collins, Colorado, United States, 80528
        • Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Research Site
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • Bradenton, Florida, United States, 34201
        • Research Site
      • DeLand, Florida, United States, 32720
        • Research Site
      • Fort Myers, Florida, United States, 33912
        • Research Site
      • Hallandale Beach, Florida, United States, 33009
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Research Site
      • Maitland, Florida, United States, 32751
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Miami, Florida, United States, 33143
        • Research Site
      • Naples, Florida, United States, 34102
        • Research Site
      • Orlando, Florida, United States, 32801
        • Research Site
      • Sunrise, Florida, United States, 33351
        • Research Site
      • Winter Haven, Florida, United States, 33880
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Atlanta, Georgia, United States, 30331
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Lisle, Illinois, United States, 60532
        • Research Site
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Research Site
      • Owensboro, Kentucky, United States, 42303
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Research Site
      • North Attleboro, Massachusetts, United States, 02760
        • Research Site
      • Springfield, Massachusetts, United States, 01104
        • Research Site
      • Watertown, Massachusetts, United States, 02472
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Research Site
      • Farmington Hills, Michigan, United States, 48334
        • Research Site
      • Jackson, Michigan, United States, 49201
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Research Site
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Research Site
      • Springfield, Missouri, United States, 65807
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Research Site
      • Reno, Nevada, United States, 89502
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11229
        • Research Site
      • Brooklyn, New York, United States, 11213
        • Research Site
      • Hartsdale, New York, United States, 10530
        • Research Site
      • Rochester, New York, United States, 14609
        • Research Site
      • Staten Island, New York, United States, 10312
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Research Site
      • Greensboro, North Carolina, United States, 27405
        • Research Site
      • High Point, North Carolina, United States, 27265
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Research Site
    • Ohio
      • Dayton, Ohio, United States, 45424
        • Research Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Research Site
      • Norman, Oklahoma, United States, 73069
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Research Site
      • Smithfield, Pennsylvania, United States, 15478
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Chattanooga, Tennessee, United States, 37421
        • Research Site
      • Kingsport, Tennessee, United States, 37660
        • Research Site
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Austin, Texas, United States, 78745
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77081
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Research Site
      • Virginia Beach, Virginia, United States, 23454
        • Research Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)

  • History of migraine ≥ 12 months with

    • ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening
    • During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary
  • No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization
  • Headache eDiary was completed on at least 25 of the 28 days prior to randomization

Exclusion Criteria:

  • Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any pain syndrome that requires regular analgesia
  • Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening
  • History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
  • Unable to differentiate migraine from other headaches
  • Have any clinically significant concurrent medical condition
  • Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
  • Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALD403 Dose Level 1
ALD403 Dose Level 1 (IV)
Drug: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 2
ALD403 Dose Level 2 (IV)
Drug: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Experimental: ALD403 Dose Level 3
ALD403 Dose Level 3 (IV)
Drug: ALD403
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
Placebo Comparator: Placebo
Placebo (IV)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Monthly Migraine Days (Weeks 1-12)
Time Frame: Week 1-12
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
Week 1-12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
75% Migraine Responder Rate
Time Frame: Week 1-12
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Week 1-12
75% Headache Responder Rate
Time Frame: Week 1-12
Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.
Week 1-12
50% Headache Responder Rate
Time Frame: Week 1-12
Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.
Week 1-12
Change From Baseline in Monthly Headache Days (Weeks 1-12)
Time Frame: Week 1-12
Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.
Week 1-12
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
Time Frame: Week 1-12
The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Week 1-12
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Time Frame: Week 1-12
Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
Week 1-12
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Time Frame: Baseline to Week 12
The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.
Baseline to Week 12
75% Migraine Responder Rate
Time Frame: Week 1-4
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.
Week 1-4
50% Migraine Responder Rate
Time Frame: Week 1-12
Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
Week 1-12
Percentage of Participants With a Migraine on the Day After Dosing
Time Frame: 1 day
The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment day and Day 1 is the day after dosing
1 day
100% Migraine Responder Rate
Time Frame: Week 1-12
Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline
Week 1-12
100% Headache Responder Rate
Time Frame: Week 1-12
Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.
Week 1-12
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
Time Frame: Week 1-12
The change in number of days with any triptan or ergotamine use as recorded in the eDiary.
Week 1-12
Change From Baseline in Average Daily Migraine Prevalence to Week 4
Time Frame: Baseline to Week 4
The change in the percentage of days where a participant has a migraine from baseline to Week 4.
Baseline to Week 4
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
Time Frame: Week 1-12
The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Week 1-12
Percent of Headaches With Severe Intensity
Time Frame: Week 1-12
Summary of percent of headaches with severe intensity over Weeks 1-12.
Week 1-12
Percent of Migraines With Severe Intensity
Time Frame: Week 1-12
Summary of percent of migraines with severe intensity over Week 1-12.
Week 1-12
Change From Baseline in Monthly Migraine Hours (Weeks 1-12)
Time Frame: Week 1-12
Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.
Week 1-12
Health Related Quality of Life (EQ-5D-5L) at Week 12
Time Frame: Week 12
The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimension/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
Week 12
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
Time Frame: Baseline to Week 12
The ASC-12 includes 12 questions about the frequency of various allodynia symptoms in association with headache attacks. For individuals with more than one type of headache, questions are directed to the "most severe type of headache." Each item is measured in a Likert type scale option with response categories: "Does not apply to me", "never", "rarely", "less than half the time", and "half the time or more". ASC items were scored as 0 (i.e., never, rarely or does not apply to me), 1 (less than half the time), and 2 (half the time or more), yielding scores that ranged from 0 to 24. If a single item is missing, it is scored as a 0. If more than one item is missing the total score will be missing. The interpretation of the total score is, 0-2: none; 3-5: mild; 6-8: moderate; greater than or equal to 9: severe.
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alder Biopharmaceuticals, Inc.

Investigators

  • Study Director: Tim Whitaker, MD, Alder Biopharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 4, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD403-CLIN-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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