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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
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
Secondary ID [1] 0 0
ALD403-CLIN-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine Disorders 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
75% Migraine Responder Rate
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
50% Migraine Responder Rate
Timepoint [1] 0 0
Weeks 1-12
Secondary outcome [2] 0 0
50% Headache Responder Rate
Timepoint [2] 0 0
Weeks 1-12
Secondary outcome [3] 0 0
100% Headache Responder Rate
Timepoint [3] 0 0
Weeks 1-12
Secondary outcome [4] 0 0
100% Migraine Responder Rate
Timepoint [4] 0 0
Weeks 1-12
Secondary outcome [5] 0 0
The Change From Baseline in Monthly Headache Days, Weeks 1-12
Timepoint [5] 0 0
Weeks 1-12
Secondary outcome [6] 0 0
The Change From Baseline in Monthly Migraine Days, Weeks 1-12
Timepoint [6] 0 0
Weeks 1-12
Secondary outcome [7] 0 0
Change From Baseline in Percentage of Severe Migraines
Timepoint [7] 0 0
Weeks 1-12
Secondary outcome [8] 0 0
Change From Baseline in Percentage of Severe Headaches
Timepoint [8] 0 0
Weeks 9-12
Secondary outcome [9] 0 0
The Change From Baseline to Week 12 in HIT-6 Total Score
Timepoint [9] 0 0
Baseline to 12
Secondary outcome [10] 0 0
Percent Change From Baseline in Headache Days
Timepoint [10] 0 0
Weeks 1-12
Secondary outcome [11] 0 0
Percent Change From Baseline in Migraine Days
Timepoint [11] 0 0
Weeks 1-12
Secondary outcome [12] 0 0
Time to First Migraine After Dosing
Timepoint [12] 0 0
Baseline to Week 49 (End of Study)
Secondary outcome [13] 0 0
Change From Baseline in Monthly Migraine Attacks, Weeks 1-12
Timepoint [13] 0 0
Weeks 1-12
Secondary outcome [14] 0 0
Change From Baseline in Monthly Headache Episodes, Weeks 1-12
Timepoint [14] 0 0
Weeks 1-12
Secondary outcome [15] 0 0
Change From Baseline in Monthly Migraine Hours, Weeks 1-12
Timepoint [15] 0 0
Weeks 1-12
Secondary outcome [16] 0 0
Change From Baseline in Monthly Headache Hours, Weeks 1-12
Timepoint [16] 0 0
Weeks 1-12
Secondary outcome [17] 0 0
Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication
Timepoint [17] 0 0
Weeks 9-12
Secondary outcome [18] 0 0
Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication
Timepoint [18] 0 0
Weeks 9-12
Secondary outcome [19] 0 0
Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12
Timepoint [19] 0 0
Baseline to Week 12

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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
665
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
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Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
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Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
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Oregon
Country [24] 0 0
United States of America
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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Texas
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United States of America
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Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Georgia
State/province [31] 0 0
Tbilisi
Country [32] 0 0
New Zealand
State/province [32] 0 0
Auckland
Country [33] 0 0
New Zealand
State/province [33] 0 0
Christchurch
Country [34] 0 0
New Zealand
State/province [34] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alder Biopharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeff TL Smith, MD
Address 0 0
Alder Biopharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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