check_circleStudy Completed
Multiple Sclerosis
Bayer Identifier:
14438
ClinicalTrials.gov Identifier:
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.
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
BothAge
12 - 16 YearsTrial summary
Enrollment Goal
68Trial Dates
December 2009 - September 2016Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 populationdate_rangeTime Frame:Up 24 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Proportion of patients being relapse freedate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Time to first relapsedate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Annualized relapse ratedate_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Disability progression measured by the expanded disability status scale (EDSS)date_rangeTime Frame:Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Outcome on neurological functione.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 monthsenhanced_encryptionNoSafety Issue:
- 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 lesionsdate_rangeTime Frame:Up to 24 months
- MRI measurements and potential correlation with neuropsychological impairmentdate_rangeTime Frame:Up to 24 months
- Laboratory outcomesLaboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GTdate_rangeTime Frame:Up to 24 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A