check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

BEYOND pilot study

Trial purpose

The purpose of this study is to valuate safety and tolerability of Betaseron.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years

Trial summary

Enrollment Goal
71
Trial Dates
November 2002 - June 2003
Phase
Phase 2
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Ohio State University Medical CenterColumbus, 43210-1240, United States
Completed
University of Kansas Medical CenterKansas City, 66160, United States
Completed
University of Chicago HospitalsChicago, 60637-1470, United States
Completed
Vanderbilt University Medical CenterNashville, 37232, United States
Completed
George Washington UniversityWashington, 20037, United States
Completed
University of Michigan Health SystemAnn Arbor, 48109-0330, United States
Completed
Shepherd CenterAtlanta, 30309-1465, United States
Completed
Louisville Neuroscience Research Center, LLCLouisville, 40205, United States
Completed
High Point Neurological AssociatesHigh Point, 27262, United States
Completed
University of Nevada-RenoReno, 89557-0035, United States
Completed
SUNY at Stony BrookStony Brook, 11794, United States
Completed
Wake Forest University Medical CenterWinston-Salem, 27157-1009, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
University of California, Los AngelesLos Angeles, 90095, United States

Primary Outcome

  • To evaluate the safety and tolerability of IFNB-1b 500 mcg given subcutaneously (SC) QOD compared with the standard dose of 250 mcg QOD in patients with RRMS.
    date_rangeTime Frame:
    8 Months
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Double-blind, randomized, parallel group, multicenter study of the safety and tolerability of Betaseron 500 mcg subcutaneously every other day and Betaseron 250 mcg subcutaneously every other day for at least 12 weeks in patients with RRMS
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2