Trial Condition(s):

Multiple Sclerosis

Study to compare double-dose Betaferon to the approved dose, for patients with early secondary progressive Multiple Sclerosis (SPMS)

Bayer Identifier:

91449

ClinicalTrials.gov Identifier:

NCT00313976

EudraCT Number:

Not Available

Terminated/Withdrawn

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).

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

Trial Summary

Enrollment Goal
0
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Hillerød Sygehus

Hillerød, Denmark, DK-3400

Status
Terminated
 
Locations

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden, 14186

Status
Terminated
 
Locations

Karolinska University Hospital

Stockholm, Sweden, 171 76

Status
Terminated
 
Locations

St Görans Sjukhus

Stockholm, Sweden, 11281

Status
Terminated
 
Locations

H:S Rigshospitalet

Copenhagen, Denmark, DK-2100

Status
Terminated
 
Locations

Holstebro Sygehus, sygehus i Ring

Holstebro, Denmark, DK-7500

Status
Terminated
 
Locations

Investigative Site

ask Contact, Denmark

Status
Terminated
 

Trial Design