Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)

May 27, 2020 updated by: Alder Biopharmaceuticals, Inc.

A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine

The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1121

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

  • Belgium
      • Brussels, Belgium, 1090
        • Research Site
      • Liege, Belgium, 4000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
  • Czechia
      • Brno, Czechia, 61500
        • Research Site
      • Choceň, Czechia, 565 01
        • Research Site
      • Prague, Czechia, 18200
        • Research Site
      • Praha, Czechia, 100 34
        • Research Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Research Site
      • Viborg, Denmark, 8800
        • Research Site
  • Georgia
      • Tbilisi, Georgia, 0160
        • Research Site
      • Tbilisi, Georgia, 0179
        • Research Site
      • Tbilisi, Georgia, 0186
        • Research Site
      • Tbilisi, Georgia, 0112
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Research Site
      • Erlangen, Germany, 91054
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Nordheim, Germany, 45122
        • Research Site
      • Unterhaching, Germany, 82008
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1145
        • Research Site
      • Budapest, Hungary, 1033
        • Research Site
      • Pecs, Hungary, 7623
        • Research Site
  • Italy
      • Ancona, Italy, 60020
        • Research Site
      • Milano, Italy, 20132
        • Research Site
      • Milano, Italy, 20133
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Roma, Italy, 00163
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Research Site
      • Kazan', Russian Federation, 420064
        • Research Site
      • Krasnoyarsk, Russian Federation, 660037
        • Research Site
      • Moscow, Russian Federation, 121467
        • Research Site
      • Novosibirsk, Russian Federation, 630051
        • Research Site
      • Novosibirsk, Russian Federation, 630054
        • Research Site
      • Saint Petersburg, Russian Federation, 194044
        • Research Site
      • Saint Petersburg, Russian Federation, 191144
        • Research Site
      • Saint Petersburg, Russian Federation, 194223
        • Research Site
      • Yaroslavl', Russian Federation, 150030
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97404
        • Research Site
      • Dolný Kubín, Slovakia, 026 01
        • Research Site
      • Dubnica nad Vahom, Slovakia, 01841
        • Research Site
      • Krompachy, Slovakia, 053 42
        • Research Site
  • Spain
      • Alicante, Spain, 03010
        • Research Site
      • Barcelona, Spain, 08035
        • Research Site
      • Guadalajara, Spain, 19002
        • Research Site
      • Lleida, Spain, 25198
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28050
        • Research Site
      • Madrid, Spain, 28222
        • Research Site
      • Madrid, Spain, 28223
        • Research Site
      • Navarrés, Spain, 31008
        • Research Site
      • Santander, Spain, 39008
        • Research Site
      • Sevilla, Spain, 41013
        • Research Site
      • Terrassa, Spain, 08221
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
      • Valladolid, Spain, 47005
        • Research Site
  • Ukraine
      • Dnipropetrovs'k, Ukraine, 49045
        • Research Site
      • Dnipropetrovsk, Ukraine, 49027
        • Research Site
      • Ivano-Frankivs'k, Ukraine, 76008
        • Research Site
      • Kharkiv, Ukraine, 61103
        • Research Site
      • Kharkiv, Ukraine, 61068
        • Research Site
      • L'viv, Ukraine, 79010
        • Research Site
      • Odessa, Ukraine, 65014
        • Research Site
      • Vinnytsia, Ukraine, 21005
        • Research Site
      • Zaporizhzhya, Ukraine, 69065
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Research Site
      • Inverness, United Kingdom, IV2 3UJ
        • Research Site
      • London, United Kingdom, SE5 9PL
        • Research Site
      • Newcastle, United Kingdom, NE1 4LP
        • Research Site
      • Salford, United Kingdom, M8 8HD
        • Research Site
      • Stoke-on-Trent, United Kingdom, ST4 7LN
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Research Site
    • California
      • Carlsbad, California, United States, 92011
        • Research Site
      • Oceanside, California, United States, 92056
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • Oxnard, California, United States, 93030
        • Research Site
      • Palo Alto, California, United States, 94304
        • Research Site
      • Redlands, California, United States, 92374
        • Research Site
      • San Diego, California, United States, 92108
        • Research Site
      • Santa Monica, California, United States, 90404
        • Research Site
      • Torrance, California, United States, 90502
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Research Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Research Site
      • Miami, Florida, United States, 33155
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Tampa, Florida, United States, 33606
        • Research Site
      • West Palm Beach, Florida, United States, 33407
        • Research Site
      • Winter Haven, Florida, United States, 33880
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Decatur, Georgia, United States, 30030
        • Research Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Research Site
      • Chicago, Illinois, United States, 60607
        • Research Site
      • Chicago, Illinois, United States, 60642
        • Research Site
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States, 50309
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Research Site
      • Prairie Village, Kansas, United States, 66208
        • Research Site
      • Wichita, Kansas, United States, 67207
        • Research Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Research Site
    • Maryland
      • Waldorf, Maryland, United States, 20603
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Research Site
      • North Attleboro, Massachusetts, United States, 02740
        • Research Site
      • Watertown, Massachusetts, United States, 02472
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • 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
      • Saint Peters, Missouri, United States, 63303
        • Research Site
      • Springfield, Missouri, United States, 65810
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Research Site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Research Site
    • New York
      • Amherst, New York, United States, 14226
        • Research Site
      • Brooklyn, New York, United States, 11229
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
      • New York, New York, United States, 10019
        • Research Site
      • Plainview, New York, United States, 11803
        • Research Site
      • Rochester, New York, United States, 14609
        • Research Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Research Site
      • High Point, North Carolina, United States, 27262
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Site
      • Dayton, Ohio, United States, 45432
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Research Site
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Research Site
      • Smithfield, Pennsylvania, United States, 15478
        • Research Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Chattanooga, Tennessee, United States, 37421
        • Research Site
      • Memphis, Tennessee, United States, 38119
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75214
        • Research Site
      • Houston, Texas, United States, 77058
        • Research Site
      • Houston, Texas, United States, 77081
        • Research Site
      • North Richland Hills, Texas, United States, 76180
        • Research Site
      • San Antonio, Texas, United States, 78258
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Research Site
      • Salt Lake City, Utah, United States, 84123
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Research Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Research Site
      • Spokane, Washington, United States, 99202
        • 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
  • During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
  • Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

Exclusion Criteria:

  • Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
  • Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
  • Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
  • History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
  • Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
  • 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ALD403 (Eptinezumab) Dose Level 1
ALD403 (Eptinezumab) Dose Level 1 (IV)
Biological: ALD403 (Eptinezumab)
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
EXPERIMENTAL: ALD403 (Eptinezumab) Dose Level 2
ALD403 (Eptinezumab) Dose Level 2 (IV)
Biological: ALD403 (Eptinezumab)
Other Names:
  • Eptinezumab-jjmr
  • Vyepti
PLACEBO_COMPARATOR: Placebo
Placebo (IV)
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Monthly Migraine Days
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% Migraine Responder Rate - 4 Week
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: Day 1
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.
Day 1
Change in Monthly Acute Medication Days
Time Frame: Week 1-12
An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.
Week 1-12
Change From Baseline of Headache Impact Test (HIT-6) Score
Time Frame: Baseline to Week 12
The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).
Baseline to Week 12
Change in Migraine Prevalence From Baseline to Week 4
Time Frame: Baseline to Week 4
The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.
Baseline to Week 4
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
100% Migraine Responder Rate
Time Frame: Week 1-12
For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.
Week 1-12
100% Headache Responder Rate
Time Frame: Week 1-12
For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.
Week 1-12
Change From Baseline in Monthly Migraine Days (Weeks 13-24)
Time Frame: Week 13-24
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.
Week 13-24
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
Time to First Migraine After Dosing
Time Frame: 32 weeks
The time to first migraine after dosing based upon the migraine data entered into the eDiary
32 weeks
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 migraine will be included with a rate of zero.
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
Percent Change in Frequency of Migraine Days - Week 1-12
Time Frame: Week 1-12
The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.
Week 1-12
Percent Change in Frequency of Headache Days - Week 1-12
Time Frame: Week 1-12
The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.
Week 1-12
Change From Baseline in Percentage of Severe Migraines
Time Frame: Week 1-12
The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.
Week 1-12
Change From Baseline in Percentage of Severe Headache
Time Frame: Week 1-12
The change from baseline in percentage of headaches that are classified as severe over Weeks 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 migraines within 4 week intervals, and the average 4 week duration within 12 weeks.
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
Duration of Migraine-Free Intervals
Time Frame: 32 weeks
The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.
32 weeks
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
Patient Global Impression of Change (PGIC) at Week 12
Time Frame: Week 12
The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
Week 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 dimensions/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

Collaborators and Investigators

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

Sponsor

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 (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

April 1, 2018

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (ESTIMATE)

November 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALD403-CLIN-011

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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