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:

NCT01491100

EudraCT Number:

Not Available

Study Completed

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

1085

Trial Dates

April2012

April2017

Phase

Could I receive a placebo?

Products

Betaseron (Interferon beta-1b, BAY86-5046)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Investigative Site Many Locations, Germany	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Albania	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, France	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Netherlands	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Czech Republic	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Israel	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Portugal	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Argentina	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Hungary	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Greece	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Egypt	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Kazakhstan	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Saudi Arabia	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Tunisia	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Belgium	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Turkey	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Many Locations, Algeria	Status Completed	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:

Primary Outcome

Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)
Timeframe: 24 months

Physical activity as measured by the Baecke questionnaire
Timeframe: 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

Multiple Sclerosis

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

12 Years

70 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information