check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
2008/01743
ClinicalTrials.gov Identifier:
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
AllAge
NaN - 18 YearsTrial summary
Enrollment Goal
70Trial Dates
June 2008 - April 2009Phase
N/ACould I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Russia |
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.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 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.date_rangeTime Frame:Up to 2 years
- Mean frequency of complications recorded after start of betaferon therapydate_rangeTime Frame: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.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 drugdate_rangeTime Frame:Up to 2 years
- Number of mild, moderate, or severe adverse eventsdate_rangeTime Frame:Up to 2 years
- Number of serious adverse events described during the trialdate_rangeTime Frame:Up to 2 years
- Number of adverse events described during the trial and classified as an flu-like syndromedate_rangeTime Frame:Up to 2 years
- Number of adverse events described during the trial and classified as a local reactiondate_rangeTime Frame:Up to 2 years
- Number of cases of betaferon discontinuation due to adverse eventsdate_rangeTime Frame:Up to 2 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A