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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALD403
Placebo
Sponsored by
Alder Biopharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ALD403 Dose Level 1

ALD403 Dose Level 2

ALD403 Dose Level 3

Placebo

Arm Description

ALD403 Dose Level 1 (IV)

ALD403 Dose Level 2 (IV)

ALD403 Dose Level 3 (IV)

Placebo (IV)

Outcomes

Primary Outcome Measures

Change From Baseline in Monthly Migraine Days (Weeks 1-12)
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

Secondary Outcome Measures

75% Migraine Responder Rate
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
75% Migraine Responder Rate
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.
50% Migraine Responder Rate
Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
Percentage of Participants With a Migraine on the Day After Dosing
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
75% Headache Responder Rate
Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.
50% Headache Responder Rate
Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.
100% Migraine Responder Rate
Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline
100% Headache Responder Rate
Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
The change in number of days with any triptan or ergotamine use as recorded in the eDiary.
Change From Baseline in Average Daily Migraine Prevalence to Week 4
The change in the percentage of days where a participant has a migraine from baseline to Week 4.
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Change From Baseline in Monthly Headache Days (Weeks 1-12)
Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.
Percent of Headaches With Severe Intensity
Summary of percent of headaches with severe intensity over Weeks 1-12.
Percent of Migraines With Severe Intensity
Summary of percent of migraines with severe intensity over Week 1-12.
Change From Baseline in Monthly Migraine Hours (Weeks 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.
Change From Baseline in Monthly Headache Hours, Weeks 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.
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
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.
Health Related Quality of Life (EQ-5D-5L) at 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.
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
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.

Full Information

First Posted
September 22, 2015
Last Updated
May 4, 2020
Sponsor
Alder Biopharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02559895
Brief Title
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Acronym
PROMISE 1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alder Biopharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
898 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALD403 Dose Level 1
Arm Type
Experimental
Arm Description
ALD403 Dose Level 1 (IV)
Arm Title
ALD403 Dose Level 2
Arm Type
Experimental
Arm Description
ALD403 Dose Level 2 (IV)
Arm Title
ALD403 Dose Level 3
Arm Type
Experimental
Arm Description
ALD403 Dose Level 3 (IV)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (IV)
Intervention Type
Drug
Intervention Name(s)
ALD403
Other Intervention Name(s)
Eptinezumab-jjmr, Vyepti
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Monthly Migraine Days (Weeks 1-12)
Description
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
Time Frame
Week 1-12
Secondary Outcome Measure Information:
Title
75% Migraine Responder Rate
Description
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Time Frame
Week 1-12
Title
75% Migraine Responder Rate
Description
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.
Time Frame
Week 1-4
Title
50% Migraine Responder Rate
Description
Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
Time Frame
Week 1-12
Title
Percentage of Participants With a Migraine on the Day After Dosing
Description
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
Time Frame
1 day
Title
75% Headache Responder Rate
Description
Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.
Time Frame
Week 1-12
Title
50% Headache Responder Rate
Description
Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.
Time Frame
Week 1-12
Title
100% Migraine Responder Rate
Description
Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline
Time Frame
Week 1-12
Title
100% Headache Responder Rate
Description
Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.
Time Frame
Week 1-12
Title
Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)
Description
The change in number of days with any triptan or ergotamine use as recorded in the eDiary.
Time Frame
Week 1-12
Title
Change From Baseline in Average Daily Migraine Prevalence to Week 4
Description
The change in the percentage of days where a participant has a migraine from baseline to Week 4.
Time Frame
Baseline to Week 4
Title
Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
Description
The percentage of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Time Frame
Week 1-12
Title
Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
Description
The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Time Frame
Week 1-12
Title
Change From Baseline in Monthly Headache Days (Weeks 1-12)
Description
Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.
Time Frame
Week 1-12
Title
Percent of Headaches With Severe Intensity
Description
Summary of percent of headaches with severe intensity over Weeks 1-12.
Time Frame
Week 1-12
Title
Percent of Migraines With Severe Intensity
Description
Summary of percent of migraines with severe intensity over Week 1-12.
Time Frame
Week 1-12
Title
Change From Baseline in Monthly Migraine Hours (Weeks 1-12)
Description
Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.
Time Frame
Week 1-12
Title
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Description
Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
Time Frame
Week 1-12
Title
Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
Description
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.
Time Frame
Baseline to Week 12
Title
Health Related Quality of Life (EQ-5D-5L) at Week 12
Description
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.
Time Frame
Week 12
Title
Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Whitaker, MD
Organizational Affiliation
Alder Biopharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Research Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Site
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Research Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Research Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Research Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Research Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Research Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Research Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Research Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Research Site
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Research Site
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Research Site
City
Lisle
State/Province
Illinois
ZIP/Postal Code
60532
Country
United States
Facility Name
Research Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Research Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Research Site
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
Facility Name
Research Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Research Site
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11213
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Research Site
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Research Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Research Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Research Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Research Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Research Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Research Site
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Research Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia

12. IPD Sharing Statement

Citations:
PubMed Identifier
36284281
Citation
Pozo-Rosich P, Dodick DW, Ettrup A, Hirman J, Cady R. Shift in diagnostic classification of migraine after initiation of preventive treatment with eptinezumab: post hoc analysis of the PROMISE studies. BMC Neurol. 2022 Oct 25;22(1):394. doi: 10.1186/s12883-022-02914-9.
Results Reference
derived
PubMed Identifier
35436857
Citation
Apelian R, Boyle L, Hirman J, Asher D. Measuring dose-related efficacy of eptinezumab for migraine prevention: post hoc analysis of PROMISE-1 and PROMISE-2. J Headache Pain. 2022 Apr 18;23(1):48. doi: 10.1186/s10194-022-01418-8.
Results Reference
derived
PubMed Identifier
35302389
Citation
Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 Jul;42(8):696-704. doi: 10.1177/03331024221077646. Epub 2022 Mar 18.
Results Reference
derived
PubMed Identifier
35131090
Citation
Martin V, Nagy AJ, Janelidze M, Giorgadze G, Hirman J, Cady R, Mehta L, Buse DC. Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2. Clin Ther. 2022 Mar;44(3):389-402. doi: 10.1016/j.clinthera.2022.01.006. Epub 2022 Feb 5.
Results Reference
derived
PubMed Identifier
35130836
Citation
Lipton RB, Charleston L 4th, Tassorelli C, Brevig T, Hirman J, Cady R. Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a >/= 75% response to eptinezumab: subgroup pooled analysis of the PROMISE trials. J Headache Pain. 2022 Feb 7;23(1):23. doi: 10.1186/s10194-022-01386-z.
Results Reference
derived
PubMed Identifier
34823467
Citation
Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.
Results Reference
derived
PubMed Identifier
33781209
Citation
Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5. Erratum In: J Headache Pain. 2021 May 25;22(1):46.
Results Reference
derived
PubMed Identifier
33250209
Citation
Smith TR, Janelidze M, Chakhava G, Cady R, Hirman J, Allan B, Pederson S, Smith J, Schaeffler B. Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study. Clin Ther. 2020 Dec;42(12):2254-2265.e3. doi: 10.1016/j.clinthera.2020.11.007. Epub 2020 Nov 27. Erratum In: Clin Ther. 2021 Apr;43(4):791.
Results Reference
derived
PubMed Identifier
32075406
Citation
Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Smith J. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020 Mar;40(3):241-254. doi: 10.1177/0333102420905132. Epub 2020 Feb 19.
Results Reference
derived

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A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

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