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Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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
• 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

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

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

External Links

•   Click here and search for drug information provided by the FDA
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product