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

March 9, 2015 updated by: Bayer

A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
      • Hillerød, Denmark, DK-3400
      • Holstebro, Denmark, DK-7500
      • ask Contact, Denmark
  • Sweden
      • Stockholm, Sweden, 171 76
      • Stockholm, Sweden, 14186
      • Stockholm, Sweden, 11281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250 micrograms every other day, subcutaneously for 104 weeks
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2x250 micrograms every other day, subcutaneously for 104 weeks
Experimental: Arm 2
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250 micrograms every other day, subcutaneously for 104 weeks
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2x250 micrograms every other day, subcutaneously for 104 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Magnetic Resonance Imaging (MRI): T2-lesions
Time Frame: At week 104
At week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Further Magnetic Resonance Imaging (MRI) parameters
Time Frame: At week 104
At week 104
Relapses
Time Frame: At week 104
At week 104
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
Time Frame: At week 104
At week 104
Hospitalizations
Time Frame: At week 104
At week 104
Neutralizing antibodies
Time Frame: At week 104
At week 104
Adverse events
Time Frame: At week 104
At week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91449
  • EudraCT: 2005-001540-23
  • 309560

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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