[18F]PBR111 and Microglial Activation in Multiple Sclerosis

A Study to Characterize the Novel TSPO PET Radioligand [18F]PBR111 as an in Vivo Marker of Microglial Activation in Multiple Sclerosis

Stopped earlyPhase 2MS (type not specified)NCT01428505

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: The Study was terminated because there was insufficient data to complete the study objectives

This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • [18F]PBR111

What it measured

Main measures

  • VT of [18F]PBR111

    day 30

    Smouldering inflammation

Other measures (5)

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

    8 months

    Smouldering inflammation

  • regional [18F]PBR111 VT

    1.5 years

  • White matter lesion load and distribution

    1.5 years

    MRI lesions

  • Cortical grey matter lesion load and distribution

    1.5 years

    MRI lesions

  • Genetic polymorphisms related to the TSPO gene

    1.5 years

    Smouldering inflammation

Who could take part

MS (type not specified) · 20 to 70

Show the full criteria

Inclusion criteria

1. Male or Female, aged 20-70 2. Able to read, comprehend and record information written in English. 3. Capable of giving written informed consent 4. Provide a venous blood sample that will be used for genetics research and the in vitro ligand binding assay. 5. A female subject is eligible to participate if she is willing to follow contraception guidelines or if she is of non-childbearing potential. 6. Male subjects must agree to use one of the contraception methods MS subjects: 1. Clinical or clinical and laboratory supported diagnosis of multiple sclerosis 2. EDSS score up to and including 7.5 at screening evaluation Healthy Volunteers: 1. 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 -

Exclusion criteria

1. If female, positive urine pregnancy test 2. An estimated glomerular filtration rate (eGFR) of less than 60 ml/kg/1.73m2 3. History or presence of a neurological diagnosis 4. Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with radiation exposure. 5. Family history of cancer (one or more first-degree relative diagnosed before the age of 55). 6. Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff. 7. 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). 8. Contraindications to MRI scanning 9. Any physical abnormality or functional disability which prevents the subject from acquiring a suitable position for scanning. 10. 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. 11. Unwillingness or inability to follow the procedures outlined in the protocol. -

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jul 2011

      2. Main results due

        Mar 2013

      3. Finished

        Mar 2013

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