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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID: NCT00702065
Run by: EMD Serono
People needed: 599
Starts: 2007-11-01
Expected to finish: 2010-10-01
Last updated by the study team: 2014-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Phoenix, Arizona, United States
Research Site — Las Vegas, Nevada, United States
Reseach site — Buenos Aires, Argentina
Research Site — Buenos Aires, Argentina
Research Site — Camperdown, Australia
Research Site — Melbourne, Australia
Research Site — New Lambton Heights, Australia
Research Site — Victoria, Australia
Research Site — Graz, Austria
Research Site — Linz, Austria
Research Site — Vienna, Austria
Research Site — Lomme, France
Research Site — Marseille, France
Research Site — Bad Wildbad, Germany
Research Site — Bochum, Germany
Research Site — München, Germany
Research Site — Afula, Israel
Research Site — Ashkelon, Israel
Research Site — Haifa, Israel
Research Site — Holon, Israel
Research Site — Brindisi, Italy
Research Site — Centro Bologna, Italy
Research Site — Florence, Italy
Research Site — Modena, Italy
Research Site — Palermo, Italy

Full record on ClinicalTrials.gov

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