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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02275117
Registration number
NCT02275117
Ethics application status
Date submitted
20/10/2014
Date registered
27/10/2014
Date last updated
8/04/2020
Titles & IDs
Public title
A Multicenter Assessment of ALD403 in Chronic Migraine
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Scientific 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
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Secondary ID [1]
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ALD403-CLIN-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Migraine Disorders
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: ALD403 Dose Level 1 - ALD403 Dose Level 1 (IV)
Experimental: ALD403 Dose Level 2 - ALD403 Dose Level 2 (IV)
Experimental: ALD403 Dose Level 3 - ALD403 Dose Level 3 (IV)
Experimental: ALD403 Dose Level 4 - ALD403 Dose Level 4 (IV)
Placebo comparator: Placebo - Placebo (IV)
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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75% Migraine Responder Rate
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Assessment method [1]
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Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
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Timepoint [1]
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12 Weeks
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Secondary outcome [1]
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50% Migraine Responder Rate
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Assessment method [1]
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Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline
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Timepoint [1]
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Weeks 1-12
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Secondary outcome [2]
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50% Headache Responder Rate
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Assessment method [2]
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Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline
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Timepoint [2]
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Weeks 1-12
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Secondary outcome [3]
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100% Headache Responder Rate
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Assessment method [3]
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Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline
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Timepoint [3]
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Weeks 1-12
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Secondary outcome [4]
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100% Migraine Responder Rate
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Assessment method [4]
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Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline
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Timepoint [4]
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Weeks 1-12
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Secondary outcome [5]
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The Change From Baseline in Monthly Headache Days, Weeks 1-12
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Assessment method [5]
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Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
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Timepoint [5]
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Weeks 1-12
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Secondary outcome [6]
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The Change From Baseline in Monthly Migraine Days, Weeks 1-12
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Assessment method [6]
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Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
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Timepoint [6]
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Weeks 1-12
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Secondary outcome [7]
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Change From Baseline in Percentage of Severe Migraines
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Assessment method [7]
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The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12
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Timepoint [7]
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Weeks 1-12
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Secondary outcome [8]
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Change From Baseline in Percentage of Severe Headaches
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Assessment method [8]
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The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12
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Timepoint [8]
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Weeks 9-12
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Secondary outcome [9]
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The Change From Baseline to Week 12 in HIT-6 Total Score
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Assessment method [9]
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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".
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Timepoint [9]
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Baseline to 12
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Secondary outcome [10]
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Percent Change From Baseline in Headache Days
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Assessment method [10]
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Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
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Timepoint [10]
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Weeks 1-12
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Secondary outcome [11]
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Percent Change From Baseline in Migraine Days
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Assessment method [11]
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Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.
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Timepoint [11]
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Weeks 1-12
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Secondary outcome [12]
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Time to First Migraine After Dosing
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Assessment method [12]
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The median number of days after dosing a participant had the next migraine using the eDiary as the recall method
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Timepoint [12]
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Baseline to Week 49 (End of Study)
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Secondary outcome [13]
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Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
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Assessment method [13]
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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
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Timepoint [13]
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Weeks 1-12
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Secondary outcome [14]
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Change From Baseline in Monthly Headache Episodes, Weeks 1-12
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Assessment method [14]
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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
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Timepoint [14]
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Weeks 1-12
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Secondary outcome [15]
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Change From Baseline in Monthly Migraine Hours, Weeks 1-12
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Assessment method [15]
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Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.
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Timepoint [15]
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Weeks 1-12
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Secondary outcome [16]
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Change From Baseline in Monthly Headache Hours, Weeks 1-12
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Assessment method [16]
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Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
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Timepoint [16]
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Weeks 1-12
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Secondary outcome [17]
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Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
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Assessment method [17]
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The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.
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Timepoint [17]
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Weeks 9-12
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Secondary outcome [18]
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Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
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Assessment method [18]
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The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
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Timepoint [18]
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Weeks 9-12
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Secondary outcome [19]
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Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline to Week 12
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Eligibility
Key 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
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Minimum age
18
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Maximum age
55
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2016
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Sample size
Target
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Accrual to date
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Final
665
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Research Site - Sydney
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Recruitment hospital [2]
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Research Site - Melbourne
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Recruitment hospital [3]
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Research Site - Perth
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Recruitment postcode(s) [1]
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2031 - Sydney
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3050 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Arizona
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United States of America
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Arkansas
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California
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United States of America
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Colorado
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Connecticut
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Country [7]
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United States of America
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Florida
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Country [8]
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United States of America
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Georgia
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Illinois
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Kansas
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Jersey
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New Mexico
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Georgia
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Tbilisi
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Country [34]
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New Zealand
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State/province [34]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Alder Biopharmaceuticals, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.
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Trial website
https://clinicaltrials.gov/study/NCT02275117
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Trial related presentations / publications
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. 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. doi: 10.1186/s10194-021-01253-3. Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, Cady R, Smith J. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019 Aug;39(9):1075-1085. doi: 10.1177/0333102419858355. Epub 2019 Jun 24.
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Public notes
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Contacts
Principal investigator
Name
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Jeff TL Smith, MD
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Address
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Alder Biopharmaceuticals, Inc.
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02275117
Download to PDF