Status:
COMPLETED
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
Lead Sponsor:
EMD Serono
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).
Detailed Description
This is a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study includes a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial trea...
Eligibility Criteria
Inclusion
- Male or female, between 18 and 65 years of age (inclusive, at time of informed consent)
- Has definite MS according to the McDonald criteria
- Has relapsing-remitting disease with 1 or more relapses within 12 months prior to Study Day 1
- Must have been clinically stable and not has a relapse within 28 days prior to Study Day 1
- Has MRI consistent with MS at the pre-study evaluation according to the Fazekas criteria
- Has a EDSS score from 0 to 5.5, inclusive
- Weighed between 40-120 kilogram (kg), inclusive
- If female, she must:
- be post-menopausal or surgically sterilized; or
- uses a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
- be neither pregnant nor breast-feeding
- If male, he must be willing to use contraception to avoid pregnancies
- Be willing and able to comply with study procedures for the duration of the study
- Voluntarily provides written informed consent, and for United states of America (USA) sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA)
Exclusion
- Has secondary progressive MS (SPMS) or primary progressive MS (PPMS)
- Prior use of disease modifying drugs (DMDs) within the last 3 months, or 2 or more prior treatment failures with DMDs on the basis of efficacy
- Has significant leukopenia (white blood cell count less than 0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1
- Has received cladribine, mitoxantrone, total lymphoid irradiation, myelosuppressive therapy, campath-1h, cyclophosphamide, azathioprine, methotrexate or natalizumab
- Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1
- Has compromised immune function or infection
- Has received oral or systemic corticosteroids or adrenocorticotropic hormone within 28 days prior to Study Day 1
- Has received cytokine-based therapy, intravenous immunoglobulin therapy, or plasmapheresis within 3 months prior to Study Day 1
- Has platelet and absolute neutrophil counts below the lower limit of normal range within 28 days prior to Study Day 1
- Has prior or current history of malignancy
- Has a history of persistent anemia, leukopenia, neutropenia, or thrombocytopenia after immunosuppressive therapy
- Has systemic disease that, in the opinion of the Investigator, might interfere with subject safety, compliance or evaluation of the condition under Study (for example, insulin-dependent diabetes, Lyme disease, clinically significant cardiac, hepatic, or renal disease, Human Immunodeficiency Virus, or Human T-Cell Lymphotrophic Virus Type-1)
- Has a psychiatric disorder that, in the opinion of the Investigator, was unstable or would preclude safe participation in the study
- Has allergy or hypersensitivity to gadolinium, to cladribine or any of its excipients
- Has used any investigational drug or experimental procedure within 6 months prior to Study Day 1
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
1326 Patients enrolled
Trial Details
Trial ID
NCT00213135
Start Date
April 1 2005
End Date
November 1 2008
Last Update
February 7 2014
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