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Betaseron

Phase 2

Multiple Sclerosis | Small molecule | Neurology |Bayer AG|Last Updated: Nov 9, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

Betaseron · 1 trial · 2 indications

Phase 2 1
NCT00893217BEYOND Pilot StudyMultiple Sclerosis
COMPLETED71 Analytics
PHASE2COMPLETED
BEYOND Pilot Study
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of IFNB-1b 500 mcg given subcutaneously (SC) QOD compared with the standard dose of 250 mcg QOD in patients with RRMS.
8 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2EXPERIMENTAL -

Interventions

NameTypeDescription
Betaseron (Interferon beta-1b, BAY86-5046)DRUG250 mcg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: Diagnosis of RRMS as defined by any of the following McDonald diagnostic criteria (McDonald et al 2001; see Appendix 16.1.1 \[(Protocol Appendix 5\]): * Two relapses and objective clinical evidence (history or present) of at least 2 lesions * Two relapses and objective clinical...

Countries:United States
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Frequently asked questions about Betaseron

What is Betaseron used for in Multiple Sclerosis?

Betaseron is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is currently in Phase 2 clinical development. The drug has been evaluated in a completed clinical trial for relapsing-remitting Multiple Sclerosis.

Who makes Betaseron?

Betaseron is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical development for Multiple Sclerosis.

What phase is Betaseron in?

Betaseron is in Phase 2 clinical development. It has completed one Phase 2 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved for any use.

What clinical trials is Betaseron in?

Betaseron has been studied in one completed clinical trial, identified as NCT00893217, titled the BEYOND Pilot Study. This Phase 2 trial enrolled 71 participants with relapsing-remitting Multiple Sclerosis in the United States.

Is Betaseron FDA approved?

Betaseron is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Multiple Sclerosis. The drug has completed one clinical trial but has not received regulatory approval.