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

Primary Purpose

Migraine Disorders

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ALD403 (Eptinezumab)

Placebo

About this trial

This is an interventional prevention trial for Migraine Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

ALD403 (Eptinezumab) Dose Level 1

ALD403 (Eptinezumab) Dose Level 2

Placebo

Arm Description

ALD403 (Eptinezumab) Dose Level 1 (IV)

ALD403 (Eptinezumab) Dose Level 2 (IV)

Placebo (IV)

Outcomes

Primary Outcome Measures

Change From Baseline in Monthly Migraine Days

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 - 4 Week

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.

Change in Monthly Acute Medication Days

An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.

Change From Baseline of Headache Impact Test (HIT-6) Score

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).

Change in Migraine Prevalence From 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.

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

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%.

100% Headache Responder Rate

Change From Baseline in Monthly Migraine Days (Weeks 13-24)

Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.

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.

Time to First Migraine After Dosing

The time to first migraine after dosing based upon the migraine data entered into the eDiary

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 migraine 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.

Percent Change in Frequency of Migraine Days - 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.

Percent Change in Frequency of Headache Days - 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.

Change From Baseline in Percentage of Severe Migraines

The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.

Change From Baseline in Percentage of Severe Headache

The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.

Change From Baseline in Monthly Migraine Hours, Weeks 1-12

Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.

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.

Duration of Migraine-Free Intervals

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.

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.

Patient Global Impression of Change (PGIC) at 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.

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 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.

Full Information

NCT ID

NCT02974153

First Posted

November 23, 2016

Last Updated

May 27, 2020

Sponsor

Alder Biopharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02974153

Brief Title

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

Acronym

PROMISE 2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

April 2018 (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 the efficacy and safety of ALD403 in the prevention of migraine headache in chronic 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

1121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALD403 (Eptinezumab) Dose Level 1

Arm Type

Experimental

Arm Description

ALD403 (Eptinezumab) Dose Level 1 (IV)

Arm Title

ALD403 (Eptinezumab) Dose Level 2

Arm Type

Experimental

Arm Description

ALD403 (Eptinezumab) Dose Level 2 (IV)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (IV)

Intervention Type

Biological

Intervention Name(s)

ALD403 (Eptinezumab)

Other Intervention Name(s)

Eptinezumab-jjmr, Vyepti

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Monthly Migraine Days

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 - 4 Week

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

Day 1

Title

Change in Monthly Acute Medication Days

Description

An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.

Time Frame

Week 1-12

Title

Change From Baseline of Headache Impact Test (HIT-6) Score

Description

Time Frame

Baseline to Week 12

Title

Change in Migraine Prevalence From Baseline to Week 4

Description

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.

Time Frame

Baseline to Week 4

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

Time Frame

Week 1-12

Title

100% Headache Responder Rate

Description

Time Frame

Week 1-12

Title

Change From Baseline in Monthly Migraine Days (Weeks 13-24)

Description

Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.

Time Frame

Week 13-24

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

Time to First Migraine After Dosing

Description

The time to first migraine after dosing based upon the migraine data entered into the eDiary

Time Frame

32 weeks

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 migraine 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

Percent Change in Frequency of Migraine Days - Week 1-12

Description

Time Frame

Week 1-12

Title

Percent Change in Frequency of Headache Days - Week 1-12

Description

Time Frame

Week 1-12

Title

Change From Baseline in Percentage of Severe Migraines

Description

The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.

Time Frame

Week 1-12

Title

Change From Baseline in Percentage of Severe Headache

Description

The change from baseline in percentage of headaches that are classified as severe over Weeks 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 migraines within 4 week intervals, and the average 4 week duration within 12 weeks.

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

Duration of Migraine-Free Intervals

Description

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.

Time Frame

32 weeks

Title

Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores

Description

Time Frame

Baseline to Week 12

Title

Patient Global Impression of Change (PGIC) at Week 12

Description

Time Frame

Week 12

Title

Health Related Quality of Life (EQ-5D-5L) at Week 12

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Research Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Research Site

City

Carlsbad

State/Province

California

ZIP/Postal Code

92011

Country

United States

Facility Name

Research Site

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Research Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

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Research Site

City

Oxnard

State/Province

California

ZIP/Postal Code

93030

Country

United States

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Research Site

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

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Research Site

City

Redlands

State/Province

California

ZIP/Postal Code

92374

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United States

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Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

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Research Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Research Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

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Research Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80918

Country

United States

Facility Name

Research Site

City

New London

State/Province

Connecticut

ZIP/Postal Code

06320

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

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Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

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United States

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Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

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

30328

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Research Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30030

Country

United States

Facility Name

Research Site

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60642

Country

United States

Facility Name

Research Site

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46011

Country

United States

Facility Name

Research Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

Research Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Research Site

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66208

Country

United States

Facility Name

Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

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United States

Facility Name

Research Site

City

Marrero

State/Province

Louisiana

ZIP/Postal Code

70072

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United States

Facility Name

Research Site

City

Waldorf

State/Province

Maryland

ZIP/Postal Code

20603

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United States

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Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02135

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United States

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Research Site

City

North Attleboro

State/Province

Massachusetts

ZIP/Postal Code

02740

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United States

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Research Site

City

Watertown

State/Province

Massachusetts

ZIP/Postal Code

02472

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United States

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Research Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

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United States

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Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

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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

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United States

Facility Name

Research Site

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63303

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United States

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Research Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65810

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Research Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Research Site

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

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United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Research Site

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

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

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Facility Name

Research Site

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

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United States

Facility Name

Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

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United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

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United States

Facility Name

Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45432

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Research Site

City

Scottdale

State/Province

Pennsylvania

ZIP/Postal Code

15683

Country

United States

Facility Name

Research Site

City

Smithfield

State/Province

Pennsylvania

ZIP/Postal Code

15478

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United States

Facility Name

Research Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

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

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75214

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Research Site

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Research Site

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Research Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Research Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Research Site

City

Brno

ZIP/Postal Code

61500

Country

Czechia

Facility Name

Research Site

City

Choceň

ZIP/Postal Code

565 01

Country

Czechia

Facility Name

Research Site

City

Prague

ZIP/Postal Code

18200

Country

Czechia

Facility Name

Research Site

City

Praha

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Research Site

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Research Site

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

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

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Research Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Research Site

City

Nordheim

ZIP/Postal Code

45122

Country

Germany

Facility Name

Research Site

City

Unterhaching

ZIP/Postal Code

82008

Country

Germany

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Research Site

City

Pecs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

Research Site

City

Ancona

ZIP/Postal Code

60020

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00163

Country

Italy

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Research Site

City

Kazan'

ZIP/Postal Code

420064

Country

Russian Federation

Facility Name

Research Site

City

Krasnoyarsk

ZIP/Postal Code

660037

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

121467

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630051

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630054

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

191144

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

194223

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl'

ZIP/Postal Code

150030

Country

Russian Federation

Facility Name

Research Site

City

Banska Bystrica

ZIP/Postal Code

97404

Country

Slovakia

Facility Name

Research Site

City

Dolný Kubín

ZIP/Postal Code

026 01

Country

Slovakia

Facility Name

Research Site

City

Dubnica nad Vahom

ZIP/Postal Code

01841

Country

Slovakia

Facility Name

Research Site

City

Krompachy

ZIP/Postal Code

053 42

Country

Slovakia

Facility Name

Research Site

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

Research Site

City

Lleida

ZIP/Postal Code

25198

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28223

Country

Spain

Facility Name

Research Site

City

Navarrés

ZIP/Postal Code

31008

Country

Spain

Facility Name

Research Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Terrassa

ZIP/Postal Code

08221

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Valladolid

ZIP/Postal Code

47005

Country

Spain

Facility Name

Research Site

City

Dnipropetrovs'k

ZIP/Postal Code

49045

Country

Ukraine

Facility Name

Research Site

City

Dnipropetrovsk

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivs'k

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61103

Country

Ukraine

Facility Name

Research Site

City

L'viv

ZIP/Postal Code

79010

Country

Ukraine

Facility Name

Research Site

City

Odessa

ZIP/Postal Code

65014

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21005

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhya

ZIP/Postal Code

69065

Country

Ukraine

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Research Site

City

Inverness

ZIP/Postal Code

IV2 3UJ

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SE5 9PL

Country

United Kingdom

Facility Name

Research Site

City

Newcastle

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Research Site

City

Salford

ZIP/Postal Code

M8 8HD

Country

United Kingdom

Facility Name

Research Site

City

Stoke-on-Trent

ZIP/Postal Code

ST4 7LN

Country

United Kingdom

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

36068494

Citation

Cowan RP, Marmura MJ, Diener HC, Starling AJ, Schim J, Hirman J, Brevig T, Cady R. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study. J Headache Pain. 2022 Sep 6;23(1):115. doi: 10.1186/s10194-022-01482-0.

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

35332807

Citation

McAllister P, Kudrow D, Cady R, Hirman J, Ettrup A. Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine. Cephalalgia. 2022 Sep;42(10):1005-1012. doi: 10.1177/03331024221089567. Epub 2022 Mar 25.

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

35189811

Citation

Buse DC, Winner PK, Charleston L 4th, Hirman J, Cady R, Brevig T. Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine. J Headache Pain. 2022 Feb 21;23(1):29. doi: 10.1186/s10194-022-01387-y.

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

33023473

Citation

Silberstein S, Diamond M, Hindiyeh NA, Biondi DM, Cady R, Hirman J, Allan B, Pederson S, Schaeffler B, Smith J. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. 2020 Oct 6;21(1):120. doi: 10.1186/s10194-020-01186-3.

Results Reference

derived

PubMed Identifier

32209650

Citation

Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24. Erratum In: Neurology. 2023 Aug 8;101(6):283.

Results Reference

derived

Learn more about this trial

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

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

Migraine Disorders

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial