A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT00702065

27904

Details and patient eligibility

About

This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

Full description

This is a multi-center, multi-regional observational,24 month study.

Health-related quality of life data from the MusiQoL instrument and SF-36 instrument will be collected at baseline, M6, M12, M18 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

Enrollment: 599 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient has any form of MS (confirmed by McDonald and/or Poser criteria)
2. Patient is 18 years old or more (inclusive, at time of informed consent).
3. Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)
4. Patient can be with or without treatment
5. Patient has read, understood, signed and dated informed consent form
6. Patient is able to fill in the questionnaire by him/herself

Exclusion criteria

1. CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria)
2. Patient receives or is planned to receive during the course of this study any investigational drug or experimental procedure
3. Patient suffers from dementia in the opinion of the investigator
4. Patient suffers of major medical or psychiatric illness in the opinion of the investigator

Trial design

599 participants in 2 patient groups

1

2