[18F]PBR111 and Microglial Activation in Multiple Sclerosis

NCT01428505 | Terminated Phase 2

• 1 other identifier: 115241
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study aimed to characterize \[18F\]PBR111 as an in vivo marker of microglial activation in Multiple Sclerosis. Regional binding of \[18F\]PBR111 will be quantified with PET in the brain of up to 24 patients with multiple sclerosis and up to 24 age- and gender- matched healthy volunteers.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• VT of [18F]PBR111

  Regional VT of \[18F\]PBR111 at baseline in MS patients and age- , gender-, and TSPO binding profile- matched healthy controls

  day 30

Secondary Outcomes (5)

• Test-retest variability of regional [18F]PBR111

  8 months

• regional [18F]PBR111 VT

  1.5 years

• White matter lesion load and distribution

  1.5 years

• Cortical grey matter lesion load and distribution

  1.5 years

• Genetic polymorphisms related to the TSPO gene

  1.5 years

Study Arms (1)

no treatment

OTHER

Radiation: [18F]PBR111

Interventions

[18F]PBR111 RADIATION

radioligand to assess binding to TSPO

no treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged 20-70
• Able to read, comprehend and record information written in English.
• Capable of giving written informed consent
• Provide a venous blood sample that will be used for genetics research and the in vitro ligand binding assay.
• A female subject is eligible to participate if she is willing to follow contraception guidelines or if she is of non-childbearing potential.
• Male subjects must agree to use one of the contraception methods
• MS subjects:
• Clinical or clinical and laboratory supported diagnosis of multiple sclerosis
• EDSS score up to and including 7.5 at screening evaluation
• Healthy Volunteers:
• \. Healthy control subjects defined as free from clinically significant active disease as assessed by the Principal Investigator from their medical and psychiatric past and present history

You may not qualify if:

• If female, positive urine pregnancy test
• An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2
• History or presence of a neurological diagnosis
• Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
• Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
• Any subject the investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities or subject's unwillingness to comply with all study-related procedures).
• Contraindications to MRI scanning
• Any physical abnormality or functional disability which prevents the subject from acquiring a suitable position for scanning.
• History of or suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera or MRI scanner for a period of at least 90mins.
• Unwillingness or inability to follow the procedures outlined in the protocol. -

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

2-(6-chloro-2-(4-(3-fluoropropoxy)phenyl)imidazo(1,2-a)pyridin-3-yl)-N,N-diethylacetamide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 5, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

GB (1)