check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:
16036
ClinicalTrials.gov Identifier:
NCT01491100
EudraCT Number:
Not Available
EU CT Number:
Not Available
Noninterventional study assessing cognitive function and physical activity in people with multiple sclerosis

Trial purpose

Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.

Key Participants Requirements

Sex

Both

Age

12 - 70 Years
  • - Patients with Relapsing Remitting Multiple Sclerosis
    (RRMS), and treated with Betaferon, with the decision for treatment made at the discretion of the attending physician, documented with a prescription of Betaferon by the physician
    - EDSS 0 - 6
    - Written informed consent

  • - Patients who do not meet the local indication criteria for Betaferon treatment.
    - Contraindications listed in the local SmPCs have to be considered.
    - Patients with a history of severe head trauma.
    - Patients with alcohol and/or drug abuse.
    - Patients with mental retardation.
    - Patients with learning disability.

Trial summary

Enrollment Goal
1085
Trial Dates
April 2012 - April 2017
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, Germany
Completed
Many Locations, Albania
Completed
Many Locations, France
Withdrawn
Many Locations, Poland
Completed
Many Locations, Netherlands
Withdrawn
Many Locations, Mexico
Completed
Many Locations, Czech Republic
Completed
Many Locations, Israel
Completed
Many Locations, Portugal
Completed
Many Locations, Argentina
Completed
Many Locations, Hungary
Completed
Many Locations, Greece
Completed
Many Locations, Egypt
Withdrawn
Many Locations, Bosnia And Herzegovina
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Saudi Arabia
Withdrawn
Many Locations, Lebanon
Completed
Many Locations, Tunisia
Withdrawn
Many Locations, Syria
Completed
Many Locations, Belgium
Completed
Many Locations, Turkey
Completed
Many Locations, Algeria
Withdrawn
Many Locations, Argentina
Withdrawn
Many Locations, Jordan

Primary Outcome

  • Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Physical activity as measured by the Baecke questionnaire
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Disability as measured by EDSS (Expanded Disability Status Scale)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

Study assessing Cognitive performance plus Physical activity in patients with Relapsing-Remitting MS under treatment with Betaferon®
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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