Trial Condition(s):
Multiple Sclerosis
Noninterventional study assessing cognitive function and physical activity in people with multiple sclerosis (CogniPlus)
Bayer Identifier:
16036
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Study assessing cognitive function and physical activity in people with relapsing remitting multiple sclerosis.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Albania | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Czech Republic | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Israel | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Portugal | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Hungary | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Egypt | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kazakhstan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Saudi Arabia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Tunisia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Belgium | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Algeria | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)Timeframe: 24 months
- Physical activity as measured by the Baecke questionnaireTimeframe: 24 months
Secondary Outcome
- Disability as measured by EDSS (Expanded Disability Status Scale)Timeframe: 24 months
- Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)Timeframe: 24 months
- Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)Timeframe: 24 months
- Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)Timeframe: 24 months
Additional Information
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