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

• Sponsor: AbbVie (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02606630
• Collaborator: (none)
• Enrollment: 4
• Locations: 2
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 2
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: ABT-555	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-555 ABT-555 will be administered at Visit 4 for Part 2 only	Drug: ABT-555; ABT-555 will be administered on Visit 4 in Part 2 only

Outcome Measures

Primary Outcome Measures

1. Change in translocator protein expression [Day 0 and 109 days]

   Compare 2 dynamic positron emission tomography scans to examine the effect of a single administration of ABT-555 on translocator protein expression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 141463	London		United Kingdom	SW17 ORE
2	Site Reference ID/Investigator# 141461	Whitechapel		United Kingdom	E1 2AT

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Steven Greenberg, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02606630
• Other Study ID Numbers: M14-561; 2015-001176-22
• First Posted: Nov 17, 2015
• Last Update Posted: Feb 8, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by AbbVie: Relapsing multiple sclerosis
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Feb 8, 2017