Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis

PHASE4CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

October 28, 2019

Primary Completion Date

May 27, 2025

Study Completion Date

May 27, 2025

Conditions
Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Cladribine

All participants will receive cladribine 10 mg tablets at a cumulative dosage of 3.5 mg/kg divided into 2 treatment courses as per the United States Prescribing Information (USPI) (1.75 mg/kg per treatment course; Year 1 and Year 2 treatment). Patients will be randomized 1:2:2:1 to receive a total of 2 Lumbar Punctures at specific time points during the treatment cycle.

Trial Locations (5)

19104

University of Pennsylvania, Philadelphia

53226

Medical College of Wisconsin, Milwaukee

63110

Washington University School of Medicine, St Louis

73104

Oklahoma Medical Research Foundation, Oklahoma City

75390

University of Texas Southwestern Medical Center, Dallas

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

EMD Serono

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT03963375 - Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis | Biotech Hunter | Biotech Hunter