At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
Interferon beta 1b (Betaseron, BAY86-5046) +3 moredrug
Likely dose
Betaseron (interferon beta 1b) 250 mcg or 500 mcg subcutaneously every other dayAI-extracted
Key inclusion· 4
- ✓Completion of Protocol 307000A (prior double-blind study)
- ✓Signed and dated informed consent
- ✓Negative serum pregnancy test
- ✓Agreement to adequate contraception for female patients
Key exclusion· 5
- ✕Pregnancy or lactation
- ✕History of alcohol or drug abuse
- ✕Inability to self-administer or have caregiver administer subcutaneous injections
- ✕Medical, psychiatric, or other conditions compromising ability to give informed consent, understand information, comply with protocol, or complete study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Interferon beta 1b (Betaseron, BAY86-5046) for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 63 participants across 17 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2003
First PostedOct 2005
Primary CompletionJan 2008
TodayJul 2026
First PostedOct 12, 2005
Enrollment StartJun 1, 2003
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.7 years ago
Interventions
Interferon beta 1b (Betaseron, BAY86-5046)drug
250 mcg administered s.c.(subcutaneous) every other day
Interferon beta 1b (Betaseron, BAY86-5046)drug
250 mcg administered s.c. every other day (for patients having received 500 mcg before)
Interferon beta 1b (Betaseron, BAY86-5046)drug
500 mcg administered s.c. every other day
Interferon beta 1b (Betaseron, BAY86-5046)drug
500 mcg administered s.c. every other day (for patients having received 250 mcg before)