Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-Remitting Multiple Sclerosis
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting
Intervention: Betaferon/Betaseron (Drug); Betaferon/Betaseron (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: 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)
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Primary outcome: The primary endpoint of this study is the safety and tolerability as defined by the incidence of patients experiencing flu-like syndrome, fever, myalgia, injection site reactions, asthenia, headache, and liver and bone marrow function abnormalities.
Secondary outcome: Evaluation of the neutralizing activity to IFNB-1b
Detailed description:
For the first 10 weeks of this extension study, patients will remain on the Betaseron® dosage
they were assigned in Study 307000A. At the Week 10 visit, the patients will be unblinded by
the sponsor and given their choice of drug dosage. To reflect therapeutic options, patients
on 250µg Betaseron® will be given the option to remain on that dose or to increase their
dosage to 500µg; patients on 500µg Betaseron® will be given the option to remain on that dose
or to decrease their dosage to 250µg
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer
HealthCare Pharmaceuticals, Inc.
Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Los Angeles, California 90095-1721, United States
Washington, District of Columbia 20037, United States
Atlanta, Georgia 30309, United States
Chicago, Illinois 60637-1470, United States
Kansas City, Kansas 66160, United States
Louisville, Kentucky 40202, United States
Ann Arbor, Michigan 48109-0022, United States
Reno, Nevada 89509, United States
Buffalo, New York 14215, United States
High Point, North Carolina 27262, United States
Winston-Salem, North Carolina 27157, United States
Durham, North Carolina 27710, United States
Columbus, Ohio 43210, United States
Nashville, Tennessee 37232, United States
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product
Starting date: June 2003
Ending date: January 2008
Last updated: December 21, 2007
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