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NCT00313976 Clinical Trial

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

Multiple Sclerosis Clinical Trial

Official title:
A Scandinavian, Randomized, Rater-blinded Study of Single and Double-dose Betaferon in Patients With Early Secondary Progressive Multiple Sclerosis

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00313976
Other study ID # 91449
Secondary ID EudraCT: 2005-00
Status Withdrawn
Phase Phase 3
First received April 11, 2006
Last updated March 9, 2015

Study information
Verified date December 2008
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencyDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250 micrograms every other day, subcutaneously for 104 weeks
• Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
2x250 micrograms every other day, subcutaneously for 104 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Magnetic Resonance Imaging (MRI): T2-lesions At week 104
Secondary Further Magnetic Resonance Imaging (MRI) parameters At week 104
Secondary Relapses At week 104
Secondary Changes in Expanded Disability Status Score (EDSS) and Multiple Sclerosis Impact Scale (MSIS) At week 104
Secondary Hospitalizations At week 104
Secondary Neutralizing antibodies At week 104
Secondary Adverse events At week 104
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