Study Stopped
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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
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
2 other identifiers
interventional
4
1 country
2
Brief Summary
This open-label positron emission tomography (PET) study is designed to determine the effect of ABT-555 on translocator protein expression level in participants with relapsing forms of multiple sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-sclerosis
Started Oct 2015
Shorter than P25 for phase_1 multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 8, 2017
February 1, 2017
2 months
November 13, 2015
February 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in translocator protein expression
Compare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression
Day 0 and 109 days
Study Arms (1)
ABT-555
EXPERIMENTALABT-555 will be administered at Visit 4 for Part 2 only
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (2)
Site Reference ID/Investigator# 141463
London, SW17 ORE, United Kingdom
Site Reference ID/Investigator# 141461
Whitechapel, E1 2AT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Steven Greenberg, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2015
First Posted
November 17, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
February 8, 2017
Record last verified: 2017-02