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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Shepherd Center Atlanta, United States, 30309-1465 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Nevada-Reno Reno, United States, 89509 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Kansas Medical Center Kansas City, United States, 66160 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vanderbilt University Medical Center Nashville, United States, 37212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations George Washington University Washington, United States, 20037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Michigan Health System Ann Arbor, United States, 48109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Neurologists, PSC Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations High Point Neurological Associates High Point, United States, 27262 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ohio State University Wexner Medical Center Columbus, United States, 43221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SUNY at Stony Brook Stony Brook, United States, 11794 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Chicago Hospitals Chicago, United States, 60637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wake Forest University Medical Center Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California, Los Angeles San Francisco, United States, 94117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37232 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109-0022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Los Angeles, United States, 90095-1721 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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 AbnormalitiesTimeframe: At End of Study Visit (week 234)
Secondary Outcome
- Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1bTimeframe: At End of Study Visit (week 234)
Additional Information
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