NCT00235989

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Interferon beta 1b (Betaseron, BAY86-5046)	250 mcg administered s.c.(subcutaneous) every other day
DRUG	Interferon beta 1b (Betaseron, BAY86-5046)	250 mcg administered s.c. every other day (for patients having received 500 mcg before)
DRUG	Interferon beta 1b (Betaseron, BAY86-5046)	500 mcg administered s.c. every other day
DRUG	Interferon beta 1b (Betaseron, BAY86-5046)	500 mcg administered s.c. every other day (for patients having received 250 mcg before)

Timeline

• Start date: 2003-06-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-10-12
• Last updated: 2014-05-08
• Results posted: 2009-07-03

Locations

17 sites across 1 country: United States