stop_circleTerminated/Withdrawn

Multiple Sclerosis

Bayer Identifier:

91449

ClinicalTrials.gov Identifier:

NCT00313976

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to compare double-dose Betaferon to the approved dose, for patients with early secondary progressive Multiple Sclerosis (SPMS)

Trial 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).

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
0
Trial Dates
November 2006 - February 2010
Phase
Phase 3
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Hillerød SygehusHillerød, DK-3400, Denmark
Terminated
Karolinska Universitetssjukhuset HuddingeStockholm, 14186, Sweden
Terminated
Karolinska University HospitalStockholm, 171 76, Sweden
Terminated
St Görans SjukhusStockholm, 11281, Sweden
Terminated
H:S RigshospitaletCopenhagen, DK-2100, Denmark
Terminated
Holstebro Sygehus, sygehus i RingHolstebro, DK-7500, Denmark
Terminated
ask Contact, Denmark

Primary Outcome

  • Magnetic Resonance Imaging (MRI): T2-lesions
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Further Magnetic Resonance Imaging (MRI) parameters
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None
  • Relapses
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None
  • Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS)
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None
  • Hospitalizations
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None
  • Neutralizing antibodies
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None
  • Adverse events
    date_rangeTime Frame:
    At week 104
    enhanced_encryption
    Safety Issue:
    None

Trial design

A Scandinavian, randomized, rater-blinded study of single and double-dose Betaferon in patients with early secondary progressive multiple sclerosis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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