Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Interferon beta-1b; Interferon-beta; Interferons

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