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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

April 28, 2021

Primary Completion Date

August 31, 2024

Study Completion Date

August 31, 2024

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Cladribine 10 mg oral tablet

Cladribine tablets (Mavenclad®, Merck KGaA, Darmstadt, Germany) will be given according to the label with a cumulative dose of 3.5 mg/kg body weight distributed over 2 years as one treatment course of 1.75 mg/kg per year. Each treatment course will consist of 2 weeks of treatment, one at the beginning of the first month and one at the beginning of the second month of the respective year of treatment. Each treatment week will consist of 4 or 5 days in which the participant will receive 10 mg or 20 mg (1 or 2 tablets, respectively) as a single daily dose, depending on body weight, according to the tables available in label. Upon completion of the two treatment courses, no further courses will be required in years 3 and 4.

Trial Locations (1)

9061000

Pontifical Catholic University of Rio Grande do Sul, Porto Alegre

All Listed Sponsors
collaborator

Merck S.A., Brazil, an affiliate of Merck KGaA, Darmstadt, Germany

UNKNOWN

lead

Pontificia Universidade Católica do Rio Grande do Sul

OTHER