Brief Summary
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.
Brief Title
A Multicenter Assessment of ALD403 in Chronic Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine Disorders
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Migraine Disorders
ALD403
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
55 Years
Minimum Age
18 Years
NCT Id
NCT02275117
Org Class
Industry
Org Full Name
Alder Biopharmaceuticals, Inc.
Org Study Id
ALD403-CLIN-005
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
Outcome Measure
75% Migraine Responder Rate
Outcome Time Frame
12 Weeks
Secondary Outcomes
Outcome Description
Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
Outcome Time Frame
Weeks 1-12
Outcome Measure
50% Migraine Responder Rate
Outcome Description
Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline
Outcome Time Frame
Weeks 1-12
Outcome Measure
50% Headache Responder Rate
Outcome Description
Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline
Outcome Time Frame
Weeks 1-12
Outcome Measure
100% Headache Responder Rate
Outcome Description
Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline
Outcome Time Frame
Weeks 1-12
Outcome Measure
100% Migraine Responder Rate
Outcome Description
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome Time Frame
Weeks 1-12
Outcome Measure
The Change From Baseline in Monthly Headache Days, Weeks 1-12
Outcome Description
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome Time Frame
Weeks 1-12
Outcome Measure
The Change From Baseline in Monthly Migraine Days, Weeks 1-12
Outcome Description
The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12
Outcome Time Frame
Weeks 1-12
Outcome Measure
Change From Baseline in Percentage of Severe Migraines
Outcome Description
The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12
Outcome Time Frame
Weeks 9-12
Outcome Measure
Change From Baseline in Percentage of Severe Headaches
Outcome Description
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".
Outcome Time Frame
Baseline to 12
Outcome Measure
The Change From Baseline to Week 12 in HIT-6 Total Score
Outcome Description
Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome Time Frame
Weeks 1-12
Outcome Measure
Percent Change From Baseline in Headache Days
Outcome Description
Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
Outcome Time Frame
Weeks 1-12
Outcome Measure
Percent Change From Baseline in Migraine Days
Outcome Description
The median number of days after dosing a participant had the next migraine using the eDiary as the recall method
Outcome Time Frame
Baseline to Week 49 (End of Study)
Outcome Measure
Time to First Migraine After Dosing
Outcome Description
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
Outcome Time Frame
Weeks 1-12
Outcome Measure
Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
Outcome Description
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
Outcome Time Frame
Weeks 1-12
Outcome Measure
Change From Baseline in Monthly Headache Episodes, Weeks 1-12
Outcome 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.
Outcome Time Frame
Weeks 1-12
Outcome Measure
Change From Baseline in Monthly Migraine Hours, Weeks 1-12
Outcome 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.
Outcome Time Frame
Weeks 1-12
Outcome Measure
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Outcome Description
The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
Outcome Time Frame
Weeks 9-12
Outcome Measure
Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
Outcome Description
The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
Outcome Time Frame
Weeks 9-12
Outcome Measure
Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
Outcome 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 (range: 0=worst to 100=best). Increases from baseline indicate improvement.
Outcome Time Frame
Baseline to Week 12
Outcome Measure
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
See Also Links
Url
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
55
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jelena Pavlovic
Investigator Email
jpavlovi@montefiore.org
Investigator Phone