Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)

Bayer

Status and phase: Withdrawn; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00313976

91449

309560

EudraCT: 2005-001540-23

Details and patient eligibility

About

The purpose of the study is to evaluate if the higher dose can give greater efficacy without negative impact on the adverse event profile for patients with early secondary progressive Multiple Sclerosis (SPMS).

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of MS for no less than one year and no longer than ten years
• Disease in the secondary progressive (SP) phase
• At least one relapse the last 3 years
• Treatment with an interferon for at least 6 months and with Betaferon for at least 3 months

Exclusion criteria

• Serious or acute heart disease
• Severe depression
• Serious or acute liver, kidney or bone marrow dysfunction
• Epilepsy not adequately treated
• Pregnancy or lactation
• Alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Arm 2

Experimental group

Treatment:

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)