A Multicenter Assessment of ALD403 in Chronic Migraine

Migraine Disorders Clinical Trial

Official title:

A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275117
• Other study ID #: ALD403-CLIN-005
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: March 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 chronic migraineurs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 665
• Est. completion date: November 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Diagnosis of migraine at = 35 years of age with history of chronic migraine = 1 year

• During the 28 day screening period, must have = 15 headache days of which = 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary

• Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Exclusion Criteria:

• Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, 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-III beta version, 2013), 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

• Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.

• 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

Biological:
• ALD403

• Placebo

Locations

Country	Name	City	State
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Perth	Western Australia
Australia	Research Site	Sydney	New South Wales
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
New Zealand	Research Site	Auckland
New Zealand	Research Site	Christchurch
New Zealand	Research Site	Hamilton
United States	Research Site	Albany	New York
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Amherst	New York
United States	Research Site	Anaheim	California
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	Boston	Massachusetts
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Canton	Ohio
United States	Research Site	Cary	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Encino	California
United States	Research Site	Endwell	New York
United States	Research Site	Evansville	Illinois
United States	Research Site	Fort Worth	Texas
United States	Research Site	Gainesville	Florida
United States	Research Site	Hallandale Beach	Florida
United States	Research Site	Hot Springs	Arkansas
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Jacksonville	Florida
United States	Research Site	Little Rock	Arkansas
United States	Reserach Site	Long Beach	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Mobile	Alabama
United States	Research Site	Mount Pleasant	South Carolina
United States	Research Site	New Bedford	Massachusetts
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Normal	Illinois
United States	Research Site	North Miami	Florida
United States	Research Site	Oakland	California
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orem	Utah
United States	Research Site	Orlando	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Prairie Village	Kansas
United States	Research Site	Princeton	New Jersey
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	New York
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Diego	California
United States	Research Site	San Francisco	California
United States	Research Site	Santa Monica	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Springfield	Missouri
United States	Research Site	Stamford	Connecticut
United States	Research Site	Stanford	California
United States	Research Site	Tacoma	Washington
United States	Research Site	Tampa	Florida
United States	Research Site	Ventura	California
United States	Research Site	Virginia Beach	Virginia
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Watertown	Massachusetts
United States	Research Site	Wichita	Kansas
United States	Research Site	Willow Grove	Pennsylvania
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Alder Biopharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Georgia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 Weeks
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	Weeks 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	Weeks 1-12
Secondary	100% Headache Responder Rate	Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline	Weeks 1-12
Secondary	100% Migraine Responder Rate	Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline	Weeks 1-12
Secondary	The Change From Baseline in Monthly Headache Days, Weeks 1-12	Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.	Weeks 1-12
Secondary	The Change From Baseline in Monthly Migraine Days, Weeks 1-12	Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.	Weeks 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	Weeks 1-12
Secondary	Change From Baseline in Percentage of Severe Headaches	The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12	Weeks 9-12
Secondary	The Change From Baseline to Week 12 in HIT-6 Total 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). A score of 60 or above is labeled as "severe".	Baseline to 12
Secondary	Percent Change From Baseline in Headache Days	Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.	Weeks 1-12
Secondary	Percent Change From Baseline in Migraine Days	Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.	Weeks 1-12
Secondary	Time to First Migraine After Dosing	The median number of days after dosing a participant had the next migraine using the eDiary as the recall method	Baseline to Week 49 (End of Study)
Secondary	Change From Baseline in Monthly Migraine Attacks, Weeks 1-12	The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days	Weeks 1-12
Secondary	Change From Baseline in Monthly Headache Episodes, Weeks 1-12	The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days	Weeks 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.	Weeks 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.	Weeks 1-12
Secondary	Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication	The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.	Weeks 9-12
Secondary	Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication	The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.	Weeks 9-12
Secondary	Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12	The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (range: 0=worst to 100=best). Increases from baseline indicate improvement.	Baseline to Week 12

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