NCT00213135 - A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Biotech Hunter

Enrollment

1,326

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

November 30, 2008

Study Completion Date

November 30, 2008

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Cladribine 5.25 mg/kg

Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.

DRUG

Cladribine 3.5 mg/kg

Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.

OTHER

Placebo

Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.