A Multicenter Assessment of ALD403 in Frequent Episodic Migraine

Migraine Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559895
• Other study ID #: ALD403-CLIN-006
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: December 2017

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 ALD403 in the prevention of migraine headache in frequent episodic migraineurs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 898
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• ALD403

• Placebo

Locations

Country	Name	City	State
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Anaheim	California
United States	Research Site	Anderson	South Carolina
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Atlanta	Georgia
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bradenton	Florida
United States	Research Site	Brooklyn	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chattanooga	Tennessee
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	DeLand	Florida
United States	Research Site	Durham	North Carolina
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Flowood	Mississippi
United States	Research Site	Fort Collins	Colorado
United States	Research site	Fort Myers	Florida
United States	Research Site	Fresno	California
United States	Research Site	Fullerton	California
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Hallandale Beach	Florida
United States	Research Site	Hartsdale	New York
United States	Research Site	Hialeah	Florida
United States	Research Site	High Point	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Jackson	Michigan
United States	Research Site	Kingsport	Tennessee
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lexington	Kentucky
United States	Research Site	Lisle	Illinois
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Long Beach	California
United States	Research Site	Maitland	Florida
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Montclair	California
United States	Research Site	Naples	Florida
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Norman	Oklahoma
United States	Research Site	North Attleboro	Massachusetts
United States	Research Site	Oceanside	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Owensboro	Kentucky
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Redlands	California
United States	Research Site	Reno	Nevada
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	Santa Monica	California
United States	Research Site	Sherman Oaks	California
United States	Research Site	Smithfield	Pennsylvania
United States	Research Site	Springfield	Missouri
United States	Research Site	Springfield	Massachusetts
United States	Research Site	Stamford	Connecticut
United States	Research Site	Staten Island	New York
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Sunrise	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Watertown	Massachusetts
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alder Biopharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	1 day
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	Participants with a reduction in migraine days of 100% over Weeks 1 to 12, as compared with baseline	Week 1-12
Secondary	100% Headache Responder Rate	Participants with a reduction in headache days of 100% over Weeks 1 to 12, as compared with baseline.	Week 1-12
Secondary	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.	Week 1-12
Secondary	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.	Baseline to Week 4
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 migraines 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	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	Percent of Headaches With Severe Intensity	Summary of percent of headaches with severe intensity over Weeks 1-12.	Week 1-12
Secondary	Percent of Migraines With Severe Intensity	Summary of percent of migraines with severe intensity over Week 1-12.	Week 1-12
Secondary	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.	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	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	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.	Week 12
Secondary	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.	Baseline to Week 12