check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

2008/01743

ClinicalTrials.gov Identifier:

NCT03577977

EudraCT Number:

Not Available

EU CT Number:

Not Available
Betaferon use in children and adolescents with Multiple Sclerosis

Trial purpose

The objective of this study is to determine efficacy, safety and tolerability of interferon beta-1b for multiple sclerosis (MS) in children and adolescents

Key Participants Requirements

Sex

All

Age

NaN - 18 Years
  • - patients with symptoms consistent with the diagnosis of a demyelinating CNS disease
    - patients who received at least one injection of Betaferon before age 18 (before their 18th birthday)
    - recorded use of at least one dose of Betaferon before January 1, 2008


  • - Diagnosis other then MS or a demyelinating CNS disease

Trial summary

Enrollment Goal
70
Trial Dates
June 2008 - April 2009
Phase
N/A
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Russia

Primary Outcome

  • Mean expanded disability status scale (EDSS) score at the end of trial participation
    The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
    date_rangeTime Frame:
    Up to 2 years
  • Proportion of patients having the mean EDSS score of less than or equal to 3.0 and more than or equal to 3.5 at the end of the trial
    The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
    date_rangeTime Frame:
    Up to 2 years
  • Mean frequency of complications recorded after start of betaferon therapy
    date_rangeTime Frame:
    Up to 2 years
  • Mean EDSS score on the exacerbations recorded after start of betaferon therapy
    The Expanded Disability Status Scale (EDSS) score is ranged between 1 (No disability, minimal signs in one Functional System) and 10 (death due to MS) measured in half-points on an ordinal scale.
    date_rangeTime Frame:
    Up to 2 years
  • Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drug
    date_rangeTime Frame:
    Up to 2 years
  • Number of mild, moderate, or severe adverse events
    date_rangeTime Frame:
    Up to 2 years
  • Number of serious adverse events described during the trial
    date_rangeTime Frame:
    Up to 2 years
  • Number of adverse events described during the trial and classified as an flu-like syndrome
    date_rangeTime Frame:
    Up to 2 years
  • Number of adverse events described during the trial and classified as a local reaction
    date_rangeTime Frame:
    Up to 2 years
  • Number of cases of betaferon discontinuation due to adverse events
    date_rangeTime Frame:
    Up to 2 years

Trial design

Retrospective data collection on Betaferon use in children and adolescents 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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