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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

April 11, 2006
December 18, 2008
Not Provided
Not Provided
Magnetic Resonance Imaging (MRI): T2-lesions [ Time Frame: At week 104 ]
MRI: T2-lesions at week 104
Complete list of historical versions of study NCT00313976 on ClinicalTrials.gov Archive Site
  • 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 ]
Further MRI parameters, relapses, changes in EDSS and MSIS, hospitalizations, Neutralizing antibodies and adverse events
Not Provided
Not Provided
 
Study to Compare Double-Dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
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).

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • 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 1
    Intervention: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
  • Experimental: Arm 2
    Intervention: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Sweden
 
NCT00313976
91449, EudraCT: 2005-001540-23, 309560
No
Therapeutic Area Head, Bayer Schering Pharma AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP