MedTrace Logo

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

NCT00963833 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2017-07-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Interferon beta-1b (Betaseron, BAY86-5046)

Patients under daily life treatment receiving Betaferon according to local product information.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
12 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-17
Primary Completion
2016-04-12
Completion
2016-09-01

Countries

  • Austria
  • Belgium
  • Finland
  • Germany
  • Israel
  • United Kingdom

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963833 on ClinicalTrials.gov