Cladribine Tablets for Multiple Sclerosis
Trial Summary
What is the purpose of this trial?
The purpose of this study is to explore the concept that biomarker sensitivity will detect activity in Multiple Sclerosis (MS) subjects and allow appropriate change in treatment to prevent dysfunction.
Will I have to stop taking my current medications?
The trial requires that certain medications be stopped before participation. Specifically, treatments like ocrelizumab, rituximab, natalizumab, fingolimod, teriflunomide, dimethyl fumarate, interferon, glatiramer acetate, and systemic corticosteroids must be stopped for specified periods before the trial. However, medications for spasticity or neuropathic pain can be continued if they have been stable for at least 30 days before screening.
What data supports the effectiveness of the drug Cladribine Tablets for treating multiple sclerosis?
Is cladribine safe for humans?
What makes the drug Cladribine Tablets unique for treating multiple sclerosis?
Research Team
Keith R Edwards, M.D.
Principal Investigator
MS Center of Northeastern New York, P.C.
Eligibility Criteria
This trial is for adults aged 21-65 with clinically definite Secondary Progressive Multiple Sclerosis (SPMS) who are neurologically stable and have chosen Cladribine Tablets as their treatment. Participants must be healthy otherwise, not pregnant or breastfeeding, agree to use effective contraception, and commit to follow-ups for two years post-study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Subjects will have a 28 day run-in period consisting of 2 visits at week -4 and week -2
Treatment
Participants receive cladribine tablets according to the current FDA package guidelines
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cladribine Tablets
Cladribine Tablets is already approved in European Union, United States for the following indications:
- Relapsing-remitting multiple sclerosis
- Relapsing forms of multiple sclerosis, including relapsing-remitting disease and active secondary progressive disease
- Hairy cell leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Keith Edwards, M.D.
Lead Sponsor
EMD Serono
Industry Sponsor
Dr. Shepard
EMD Serono
Chief Medical Officer since 2021
MD from University of Cincinnati Medical School, Fellowships in Hematology and Oncology at University of Chicago Hospitals and Clinics
Miguel Fernández Alcalde
EMD Serono
Chief Executive Officer
Bachelor's Degree in Pharmacy from the University Complutense in Madrid, MBA from the University of Alcalá de Henares, Master's Degree in Management from IESE Business School