CogniMS: observational study to assess cognition in patients with early Multiple Sclerosis - CogniMS

Conditions: Observational Study to assess cognition in patients with early Multiple Sclerosis.Relapsing-Remitting MS-patients diagnosed within 2 years and who have started the Betaferon treatment (interferon-beta-1b) during the last 6 months

Registration Number: EUCTR2005-005989-37-FI

Lead Sponsor: Schering Oy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

Patient selection and observation: This observational study focuses on patients with relapsing-remitting MS diagnosed within the last 2 years (according to McDonald or Poser criteria), who have started treatment with Betaferon during the last 6 months. The prescription of the medicine is clearly separated from the decision to include the patient in the study. The patients will be screened for cognitive changes, depression, HrQoL and fatigue every 6 months for 2 years. Patients are either newly recruited for CogniMS or have previously participated in the CogniCIS study until they have fulfilled diagnostic criteria for MS.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

See Inclusion Criteria.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To obtain observational data on cognitive deficit in MS and to elucidate whether cognitive function can predict the course of MS. To further validate the Faces Symbol Test (FST) and MS Neuropsychological Questionnaire(MSNQ) in a multinational setting. To study the interaction between cognition, depression, fatique and Health-related Qality of Life (HrQoL) in MS patients. To gather observational data on Betaferon adherence, safety and effectivity.;Secondary Objective: ;Primary end point(s): Observational study, observation period 6 months

Secondary Outcome Measures