Trial Condition(s):

Multiple Sclerosis

Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients with Multiple Sclerosis

Bayer Identifier:

14438

ClinicalTrials.gov Identifier:

NCT00963833

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years.

The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions.

As this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.

Inclusion Criteria
- Treatment naive children and adolescents of 12 to 16 years of age at inclusion with a diagnosis of RRMS according to revised McDonald or Poser criteria and decision taken by the investigator to treat with Betaferon. The local Betaferon product information must be considered.
Exclusion Criteria
- Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.

Trial Summary

Enrollment Goal
68
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 
Locations

Investigative Site

Many Locations, Belgium

Status
Completed
 
Locations

Investigative Site

Many Locations, Austria

Status
Completed
 
Locations

Investigative Site

Many Locations, Finland

Status
Completed
 
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, Israel

Status
Completed
 

Trial Design