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Completed

NCT Number: NCT01491100

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Albania

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.

Primary outcomes

  1. Cognitive performance as measured by SDMT (Symbol Digit Modalities Test)

    Time frame: 24 months

  2. Physical activity as measured by the Baecke questionnaire

    Time frame: 24 months

Secondary outcomes

  1. Disability as measured by EDSS (Expanded Disability Status Scale)

    Time frame: 24 months

  2. Fatigue as measured by FSMC (Fatigue Scale for Motor and Cognitive Functions)

    Time frame: 24 months

  3. Depression as measured by the CES-D (Center for Epidemiologic Studies Depression)

    Time frame: 24 months

  4. Quality of life as measured by the SF-12 (Mental and physical health-scale measure of quality of life)

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: CogniPlus

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Dec 13, 2011
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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