- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02606630
[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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London, United Kingdom, SW17 ORE
- Site Reference ID/Investigator# 141463
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Whitechapel, United Kingdom, E1 2AT
- Site Reference ID/Investigator# 141461
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ABT-555
ABT-555 will be administered at Visit 4 for Part 2 only
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ABT-555 will be administered on Visit 4 in Part 2 only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in translocator protein expression
Time Frame: Day 0 and 109 days
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Compare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression
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Day 0 and 109 days
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Steven Greenberg, MD, AbbVie
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M14-561
- 2015-001176-22 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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