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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005989-37-FI

Enrollment

2000

Registered

2006-02-17

Start date

2006-03-29

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: See Inclusion Criteria.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026