Back to resultsStudy to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Primary Purpose
Multiple Sclerosis
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Early secondary progressive Multiple Sclerosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Magnetic Resonance Imaging (MRI): T2-lesions
Secondary Outcome Measures
Further Magnetic Resonance Imaging (MRI) parameters
Relapses
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
Hospitalizations
Neutralizing antibodies
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00313976
Brief Title
Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
Official Title
A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Early secondary progressive Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Intervention Description
250 micrograms every other day, subcutaneously for 104 weeks
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Intervention Description
2x250 micrograms every other day, subcutaneously for 104 weeks
Primary Outcome Measure Information:
Title
Magnetic Resonance Imaging (MRI): T2-lesions
Time Frame
At week 104
Secondary Outcome Measure Information:
Title
Further Magnetic Resonance Imaging (MRI) parameters
Time Frame
At week 104
Title
Relapses
Time Frame
At week 104
Title
Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
Time Frame
At week 104
Title
Hospitalizations
Time Frame
At week 104
Title
Neutralizing antibodies
Time Frame
At week 104
Title
Adverse events
Time Frame
At week 104
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
ask Contact
Country
Denmark
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
City
Hillerød
ZIP/Postal Code
DK-3400
Country
Denmark
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
City
Stockholm
ZIP/Postal Code
11281
Country
Sweden
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study to Compare Double-dose Betaferon to the Approved Dose, for Patients With Early Secondary Progressive Multiple Sclerosis (SPMS)
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