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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type EXPERIMENTAL

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

Intervention Type DRUG

250 micrograms every other day, subcutaneously for 104 weeks

Arm 2

Group Type EXPERIMENTAL

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

Intervention Type DRUG

2x250 micrograms every other day, subcutaneously for 104 weeks

Interventions

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

250 micrograms every other day, subcutaneously for 104 weeks

Intervention Type DRUG

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

2x250 micrograms every other day, subcutaneously for 104 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No