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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00313976
First Posted: April 12, 2006
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose
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).

Condition Intervention Phase
Multiple Sclerosis Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Magnetic Resonance Imaging (MRI): T2-lesions [ Time Frame: At week 104 ]

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

Enrollment: 0
Arms Assigned Interventions
Experimental: Arm 1 Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250 micrograms every other day, subcutaneously for 104 weeks
Experimental: Arm 2 Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2x250 micrograms every other day, subcutaneously for 104 weeks

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313976


Locations
Denmark
ask Contact, Denmark
Copenhagen, Denmark, DK-2100
Hillerød, Denmark, DK-3400
Holstebro, Denmark, DK-7500
Sweden
Stockholm, Sweden, 11281
Stockholm, Sweden, 14186
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00313976     History of Changes
Other Study ID Numbers: 91449
EudraCT: 2005-001540-23
309560
First Submitted: April 11, 2006
First Posted: April 12, 2006
Last Update Posted: March 10, 2015
Last Verified: December 2008

Keywords provided by Bayer:
Multiple Sclerosis
Early secondary progressive Multiple Sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic