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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Other interventions - ALD403
Other interventions - Placebo
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)
Other interventions: ALD403
Other interventions: Placebo
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Intervention code [1]
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Other interventions
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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
Years
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Maximum age
55
Years
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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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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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United States of America
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State/province [4]
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California
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Country [5]
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United States of America
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State/province [5]
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Colorado
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Country [6]
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United States of America
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State/province [6]
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Connecticut
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Country [7]
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United States of America
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State/province [7]
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Florida
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Country [8]
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State/province [8]
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Georgia
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Illinois
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State/province [10]
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Kansas
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State/province [11]
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Kentucky
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Country [12]
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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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Pennsylvania
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South Carolina
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Texas
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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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Country [33]
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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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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/ct2/show/NCT02275117
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Trial related presentations / publications
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02275117
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