Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

Extension of prior study evaluating safety and tolerability of two doses of Betaseron® to treat relapsing-remitting multiple sclerosis

Bayer Identifier:

91272

ClinicalTrials.gov Identifier:

NCT00235989

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Inclusion Criteria
- Signed and dated statement of informed consent
 - Completion of Protocol 307000A
 - Negative serum pregnancy test results
 - Agreement to adequate contraception, for female patients
Exclusion Criteria
- Pregnancy or lactation
 - History of alcohol or drug abuse
 - Inability to administer subcutaneous injections either by self or by caregiver
 - Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study
 - Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study

Trial Summary

Enrollment Goal
63
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Shepherd Center

Atlanta, United States, 30309-1465

Status
Completed
 
Locations

University of Nevada-Reno

Reno, United States, 89509

Status
Completed
 
Locations

University of Kansas Medical Center

Kansas City, United States, 66160

Status
Completed
 
Locations

Vanderbilt University Medical Center

Nashville, United States, 37212

Status
Completed
 
Locations

George Washington University

Washington, United States, 20037

Status
Completed
 
Locations

University of Michigan Health System

Ann Arbor, United States, 48109

Status
Completed
 
Locations

University Neurologists, PSC

Louisville, United States, 40202

Status
Completed
 
Locations

High Point Neurological Associates

High Point, United States, 27262

Status
Completed
 
Locations

Ohio State University Wexner Medical Center

Columbus, United States, 43221

Status
Completed
 
Locations

SUNY at Stony Brook

Stony Brook, United States, 11794

Status
Completed
 
Locations

University of Chicago Hospitals

Chicago, United States, 60637

Status
Completed
 
Locations

Wake Forest University Medical Center

Winston-Salem, United States, 27157

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

University of California, Los Angeles

San Francisco, United States, 94117

Status
Completed
 
Locations

Investigative Site

Nashville, United States, 37232

Status
Completed
 
Locations

Investigative Site

Washington, United States, 20037

Status
Completed
 
Locations

Investigative Site

Durham, United States, 27710

Status
Completed
 
Locations

Investigative Site

Ann Arbor, United States, 48109-0022

Status
Completed
 
Locations

Investigative Site

Los Angeles, United States, 90095-1721

Status
Completed
 

Trial Design