[11C]-PBR28 Positron Emission Tomography Study to Evaluat... | NCT02606630

Studies
[11C]-PBR28 Positron Emission Tomography Study to Evaluate the Effect of ABT 555 in Subjects With Relapsing Forms of Multiple Sclerosis

NCT02606630

Sponsor

AbbVie

Status

Terminated

Last Update Posted

Feb 8, 2017Estimated

Enrollment

4Actual

Phase

Phase 1

Conditions

Multiple Sclerosis

Interventions

ABT-555

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-001176-22	EudraCT Number

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Nov 13, 2015

First Submission Date that Met QC Criteria

Nov 13, 2015

First Posted Date

Nov 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2017

Last Update Posted Date

Feb 8, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABT-555	Experimental	ABT-555 will be administered at Visit 4 for Part 2 only	Drug: ABT-555

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABT-555	Drug	ABT-555 will be administered on Visit 4 in Part 2 only	ABT-555

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Steven Greenberg, MD	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 141463		London		SW17 ORE	United Kingdom
Site Reference ID/Investigator# 141461

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided