Effects of Oral Cladribine on Remyelination and Inflammation in Multiple Sclerosis Patients
Status:
Active, not recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
Multiple sclerosis (MS) is a chronic, immune-mediated, demyelinating disease of the central
nervous system. Typical brain lesions of the disease may be partially repaired by an
endogenous remyelination process which is limited and tends to deplete over the course of the
disease. Cladribine tablets are an approved treatment that promotes selective lymphocyte
depletion, reducing the inflammatory activity of the disease. The present study is based on
the hypothesis that improved inflammatory control through cladribine tablets provides a
tissue microenvironment more favorable for remyelination of brain lesions in MS. This
hypothesis will be evaluated by a single-arm, open-label, phase IV, single-center,
proof-of-concept clinical trial in which 10 participants with relapsing-remitting, highly
active MS, relatively early in the course of the disease, will receive conventional treatment
with cladribine tablets and will be followed-up for 48 months. Neurological,
neuropsychological and magnetic resonance imaging (MRI) parameters will be measured.
Remyelination will be assessed by a novel MRI technique called the q-Space myelin map.
Additionally, the peripheral blood lymphocyte and cytokine profiles will be evaluated in
order to understand the immunological aspects that influence the remyelination capacity in
patients treated with cladribine tablets. The study will be conducted in accordance with
current regulations governing clinical research in Brazil.
Phase:
Phase 4
Details
Lead Sponsor:
Pontificia Universidade Católica do Rio Grande do Sul
Collaborator:
Merck S.A., Brazil, an affiliate of Merck KGaA, Darmstadt, Germany