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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02606630 |
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Date of registration:
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13/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis
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Scientific title:
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A [C-11]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT-555 on Central Nervous System Inflammation in Subjects With Relapsing Forms of Multiple Sclerosis |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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4 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02606630 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Steven Greenberg, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Diagnosis of relapsing-remitting MS (RRMS) or relapsing secondary progressive MS (SPMS)
Neurologically stable at Screening, in the investigator's judgment and not actively
experiencing or recovering from a recent relapse in the 30 days preceding the Screening
Visit
A Kurtzke Expanded Disability Status Scale (EDSS) score of 1.0 to 6.0, inclusive at the
Screening Visit
High or mixed affinity binder of the TSPO, as determined by rs6971 polymorphism genotyping
at screening
Exclusion Criteria:
Diagnosis of primary progressive or non-relapsing secondary progressive MS
Smoking more than 10 cigarettes per day or use of a nicotine patch
Known history of, or positive screening test result for hepatitis C virus or hepatitis B
virus
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks
before Screening
Any type of live virus vaccine from 4 weeks before randomization
History of abnormal laboratory results
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: ABT-555
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Primary Outcome(s)
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Change in translocator protein expression
[Time Frame: Day 0 and 109 days]
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Secondary ID(s)
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2015-001176-22
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M14-561
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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