check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

14438

ClinicalTrials.gov Identifier:

NCT00963833

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients with Multiple Sclerosis

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.

Key Participants Requirements

Sex

Both

Age

12 - 16 Years


  • - 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.


  • - Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.

Trial summary

Enrollment Goal
68
Trial Dates
December 2009 - September 2016
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United Kingdom
Withdrawn
Many Locations, Italy
Completed
Many Locations, Belgium
Withdrawn
Many Locations, Portugal
Completed
Many Locations, Austria
Completed
Many Locations, Finland
Completed
Many Locations, Germany
Completed
Many Locations, Israel

Primary Outcome

  • Safety and tolerability of Betaferon in this patient population
    date_rangeTime Frame:
    Up 24 months
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    Safety Issue:
    Yes

Secondary Outcome

  • Proportion of patients being relapse free
    date_rangeTime Frame:
    Up to 24 months
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    Safety Issue:
    No
  • Time to first relapse
    date_rangeTime Frame:
    Up to 24 months
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    Safety Issue:
    No
  • Annualized relapse rate
    date_rangeTime Frame:
    Up to 24 months
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    Safety Issue:
    No
  • Disability progression measured by the expanded disability status scale (EDSS)
    date_rangeTime Frame:
    Up to 24 months
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    Safety Issue:
    No
  • Outcome on neurological function
    e.g. IQ assessment using Standard Progressive Matrices (SPM) and Wechsler intelligence scale for children-fourth edition (WISCIV®), assessment of visual and motor integration using Beery VMI , and assessment of attention and concentration using d2 test.
    date_rangeTime Frame:
    Up to 24 months
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    Safety Issue:
    No
  • Fatigue assessed by Fatigue Severity Scale (FSS)
    date_rangeTime Frame:
    Up to 24 months
  • MRI measurements (if available)
    e.g. number of new T2 lesions, number of new contrast enhancing lesions
    date_rangeTime Frame:
    Up to 24 months
  • MRI measurements and potential correlation with neuropsychological impairment
    date_rangeTime Frame:
    Up to 24 months
  • Laboratory outcomes
    Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT
    date_rangeTime Frame:
    Up to 24 months

Trial design

Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients with Multiple Sclerosis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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