Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CogniPlus  

Official title:

Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491100
• Other study ID #: 16036
• Secondary ID: BF1101
• Status: Completed
• First received: December 12, 2011
• Last updated: April 4, 2018
• Start date: April 30, 2012
• Est. completion date: April 5, 2017

Study information

• Verified date: April 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1085
• Est. completion date: April 5, 2017
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon beta-1b (Betaseron, BAY86-5046)
Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Albania,  Algeria,  Argentina,  Belgium,  Czechia,  Egypt,  France,  Germany,  Greece,  Hungary,  Israel,  Kazakhstan,  Netherlands,  Portugal,  Saudi Arabia,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)		24 months
Primary	Physical activity as measured by the Baecke questionnaire		24 months
Secondary	Disability as measured by EDSS (Expanded Disability Status Scale)		24 months
Secondary	Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)		24 months
Secondary	Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)		24 months
Secondary	Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)		24 months

External Links

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