Effect of cladribine treatment on microglial activation in the CNS

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001960-31-FI
• Lead Sponsor: Turku PET centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-11
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

-Signing the informed consent form
-Cladribine treatment is planned and indicated and is according to label
-45-55 years of age at the time of signing the research informed consent form
-RRMS diagnosis in accordance with McDonald 2017 criteria

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Patients with other neurodegenerative disease than MS
-Abnormal lymphocyte counts
-Patients with human immunodeficiency virus (HIV).
-Patients with active chronic infection (tuberculosis or hepatitis).
-Patients with active malignancy.
-Patients with moderate or severe renal impairment (creatinine clearance <60 mL/min)
-Patients that are pregnant or breast-feeding
-Corticosteroid treatment within 4 weeks of imaging
-Patients with significant abnormal findings other than MS in a previous MRI.
-Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
-Contraindication to PET scan investigations
-Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
-Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
-Patients with previous alemtuzumab administration
-Patients with less than 6 months since previous administration of ocrelizumab or rituximab (or with abnormal B-cell counts)
-Patients with less than 1 month since previous administration of other DMT

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified