Effects of Oral Cladribine on Remyelination and Inflammation in Multiple Sclerosis Patients

Phase 4

Active, not recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Cladribine 10 mg oral tablet

• Registration Number: NCT05902429
• Lead Sponsor: Pontificia Universidade Católica do Rio Grande do Sul

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-28
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cladribine tablets	Cladribine 10 mg oral tablet	-

Primary Outcome Measures

Name	Time	Method
Proportion of remyelinated lesions (as assessed by neuroradiologist) in q-Space myelin map	36 months after initiation of cladribine tablets treatment

Secondary Outcome Measures

Name	Time	Method
Median "lesion ratio" (i.e., myelin index: lesion signal / normal appearing white matter signal) in q-Space myelin map	36 months after initiation of cladribine tablets treatment
Correlation between remyelination parameters in q-Space myelin map and evolution of clinical scores (annualized relapse rate, EDSS, MSFC and their subtests)	Over 36 months following initiation of cladribine tablets treatment
Mean signal intensity of lesions in q-Space myelin map	36 months after initiation of cladribine tablets treatment
Correlation between cytokine profile and remyelination parameters in q-Space myelin map	Transversally (at months 0, 12, 24, and 36) and longitudinally (over 36 months following initiation of cladribine tablets treatment)
Correlation between remyelination parameters in q-Space myelin map and evolution of neuropsychological scores (BICAMS and MFIS subtests)	Over 36 months following initiation of cladribine tablets treatment
Correlation between lymphocyte profile and remyelination parameters in q-Space myelin map	Transversally (at months 0, 12, 24, and 36) and longitudinally (over 36 months following initiation of cladribine tablets treatment)

Trial Locations

Locations (1)

Pontifical Catholic University of Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil