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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 terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00313976
First received: April 11, 2006
Last updated: December 18, 2008
Last verified: December 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313976

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: April 11, 2006
Last Updated: December 18, 2008
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 23, 2013