check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

91272

ClinicalTrials.gov Identifier:

NCT00235989

EudraCT Number:

Not Available

EU CT Number:

Not Available
Extension of prior study evaluating safety and tolerability of two doses of Betaseron® to treat relapsing-remitting multiple sclerosis

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - Signed and dated statement of informed consent
    - Completion of Protocol 307000A
    - Negative serum pregnancy test results
    - Agreement to adequate contraception, for female patients
  • - 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
June 2003 - January 2008
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
Shepherd CenterAtlanta, 30309-1465, United States
Completed
University of Nevada-RenoReno, 89509, United States
Completed
University of Kansas Medical CenterKansas City, 66160, United States
Completed
Vanderbilt University Medical CenterNashville, 37212, United States
Completed
George Washington UniversityWashington, 20037, United States
Completed
University of Michigan Health SystemAnn Arbor, 48109, United States
Completed
University Neurologists, PSCLouisville, 40202, United States
Completed
High Point Neurological AssociatesHigh Point, 27262, United States
Completed
Ohio State University Wexner Medical CenterColumbus, 43221, United States
Completed
SUNY at Stony BrookStony Brook, 11794, United States
Completed
University of Chicago HospitalsChicago, 60637, United States
Completed
Wake Forest University Medical CenterWinston-Salem, 27157, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
University of California, Los AngelesSan Francisco, 94117, United States
Completed
Nashville, 37232, United States
Completed
Washington, 20037, United States
Completed
Durham, 27710, United States
Completed
Durham, 27710, United States
Completed
Ann Arbor, 48109-0022, United States
Completed
Ann Arbor, 48109-0022, United States
Completed
Los Angeles, 90095-1721, United States
Completed
Los Angeles, 90095-1721, United States
Completed
Los Angeles, 90095-1721, United States

Primary Outcome

  • Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
    date_rangeTime Frame:
    At End of Study Visit (week 234)
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    Safety Issue:
    Yes

Secondary Outcome

  • Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
    date_rangeTime Frame:
    At End of Study Visit (week 234)
    enhanced_encryption
    Safety Issue:
    No

Trial design

An open-label extension study of the double-blind, randomized, parallel group, multicenter phase 2 study 307000A to further evaluate the safety and tolerability of Betaseron® 500 mcg subcutaneously every other day and Betaseron® 250 mcg subcutaneously every other day in patients with relapsing-remitting multiple sclerosis (RRMS)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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