Trial Condition(s):
Multiple Sclerosis
Betaferon use in children and adolescents with Multiple Sclerosis
Bayer Identifier:
2008/01743
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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
Inclusion Criteria
- 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
Exclusion Criteria
- Diagnosis other then MS or a demyelinating CNS disease
Trial Summary
Enrollment Goal
70
Trial Dates
Phase
N/A
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
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Mean expanded disability status scale (EDSS) score at the end of trial participationThe 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.Timeframe: 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 trialThe 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.Timeframe: Up to 2 years
- Mean frequency of complications recorded after start of betaferon therapyTimeframe: Up to 2 years
- Mean EDSS score on the exacerbations recorded after start of betaferon therapyThe 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.Timeframe: Up to 2 years
- Number of adverse events described during the trial and described as possibly, likely, or undoubtedly associated with the test drugTimeframe: Up to 2 years
- Number of mild, moderate, or severe adverse eventsTimeframe: Up to 2 years
- Number of serious adverse events described during the trialTimeframe: Up to 2 years
- Number of adverse events described during the trial and classified as an flu-like syndromeTimeframe: Up to 2 years
- Number of adverse events described during the trial and classified as a local reactionTimeframe: Up to 2 years
- Number of cases of betaferon discontinuation due to adverse eventsTimeframe: Up to 2 years
Additional Information
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