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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02606630
• Other study ID #: M14-561
• Secondary ID: 2015-001176-22
• Status: Terminated
• Phase: Phase 1
• First received: November 13, 2015
• Last updated: February 6, 2017
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• ABT-555
ABT-555 will be administered on Visit 4 in Part 2 only

Locations

Country	Name	City	State
United Kingdom	Site Reference ID/Investigator# 141463	London
United Kingdom	Site Reference ID/Investigator# 141461	Whitechapel

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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