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

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.
 
ClinicalTrials.gov Identifier: NCT00313976
Recruitment Status : Withdrawn
First Posted : April 12, 2006
Last Update Posted : March 10, 2015
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date March 10, 2015
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2008)
Magnetic Resonance Imaging (MRI): T2-lesions [ Time Frame: At week 104 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
MRI: T2-lesions at week 104
Change History Complete list of historical versions of study NCT00313976 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
Further MRI parameters, relapses, changes in EDSS and MSIS, hospitalizations, Neutralizing antibodies and adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Official Title  ICMJE A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
  • Experimental: Arm 2
    Intervention: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 18, 2008)
0
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313976
Other Study ID Numbers  ICMJE 91449
EudraCT: 2005-001540-23
309560
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Therapeutic Area Head, Bayer Schering Pharma AG
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2008

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