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

Migraine Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974153
• Other study ID #: ALD403-CLIN-011
• Status: Completed
• Phase: Phase 3
• Start date: November 2016
• Est. completion date: April 2018

Study information

• Verified date: May 2020
• Source: Alder Biopharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1121
• Est. completion date: April 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Biological:
• ALD403 (Eptinezumab)

• Placebo

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Belgium	Research Site	Liege
Belgium	Research Site	Liège
Czechia	Research Site	Brno
Czechia	Research Site	Chocen
Czechia	Research Site	Prague
Czechia	Research Site	Praha
Denmark	Research Site	Glostrup
Denmark	Research Site	Viborg
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Germany	Research Site	Berlin
Germany	Research Site	Erlangen
Germany	Research Site	Hamburg
Germany	Research Site	Nordheim
Germany	Research Site	Unterhaching
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Pecs
Italy	Research Site	Ancona
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Pavia
Italy	Research Site	Roma
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Kazan'
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Yaroslavl'
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Dolný Kubín
Slovakia	Research Site	Dubnica nad Vahom
Slovakia	Research Site	Krompachy
Spain	Research Site	Alicante
Spain	Research Site	Barcelona
Spain	Research Site	Guadalajara
Spain	Research Site	Lleida
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Navarrés
Spain	Research Site	Santander
Spain	Research Site	Sevilla
Spain	Research Site	Terrassa
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Ukraine	Research Site	Dnipropetrovs'k
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Ivano-Frankivs'k
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	L'viv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Vinnytsia
Ukraine	Research Site	Zaporizhzhya
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Inverness
United Kingdom	Research Site	London
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Salford
United Kingdom	Research Site	Stoke-on-Trent
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Amherst	New York
United States	Research Site	Anderson	Indiana
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Brooklyn	New York
United States	Research Site	Canton	Ohio
United States	Research Site	Carlsbad	California
United States	Research Site	Champaign	Illinois
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Decatur	Georgia
United States	Research Site	Des Moines	Iowa
United States	Research Site	Durham	North Carolina
United States	Research Site	Flowood	Mississippi
United States	Research Site	High Point	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Marrero	Louisiana
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mount Pleasant	South Carolina
United States	Research Site	Nashville	Tennessee
United States	Research Site	New London	Connecticut
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	North Attleboro	Massachusetts
United States	Research Site	North Richland Hills	Texas
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Orlando	Florida
United States	Research Site	Overland Park	Kansas
United States	Research Site	Oxnard	California
United States	Research Site	Palo Alto	California
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plainview	New York
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Princeton	New Jersey
United States	Research Site	Redlands	California
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Peters	Missouri
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Santa Monica	California
United States	Research Site	Scottdale	Pennsylvania
United States	Research Site	Smithfield	Pennsylvania
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Missouri
United States	Research Site	Tampa	Florida
United States	Research Site	Torrance	California
United States	Research Site	Waldorf	Maryland
United States	Research Site	Watertown	Massachusetts
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Wichita	Kansas
United States	Research Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alder Biopharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Denmark,  Georgia,  Germany,  Hungary,  Italy,  Russian Federation,  Slovakia,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Monthly Migraine Days	Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-4
Secondary	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.	Week 1-12
Secondary	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.	Day 1
Secondary	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.	Week 1-12
Secondary	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).	Baseline to Week 12
Secondary	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.	Baseline to Week 4
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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%.	Week 1-12
Secondary	100% Headache 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%.	Week 1-12
Secondary	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.	Week 13-24
Secondary	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.	Week 1-12
Secondary	Time to First Migraine After Dosing	The time to first migraine after dosing based upon the migraine data entered into the eDiary	32 weeks
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	32 weeks
Secondary	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.	Baseline to Week 12
Secondary	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.	Week 12
Secondary	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.	Week 12