Multiple Sclerosis Clinical Trial

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

Summary

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.

View Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

599

Study ID:

NCT00702065

Recruitment Status:

Completed

Sponsor:

EMD Serono

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There is 1 Location for this study

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Research Site
Phoenix Arizona, , United States
Research Site
Las Vegas Nevada, , United States
Reseach site
Buenos Aires , , Argentina
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Buenos Aires , , Argentina
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Camperdown , , Australia
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Melbourne , , Australia
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New Lambton Heights , , Australia
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Victoria , , Australia
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Graz , , Austria
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Linz , , Austria
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Wien , , Austria
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Lomme , , France
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Marseille , , France
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Bad Wildbad , , Germany
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Bochum , , Germany
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München , , Germany
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Afula , , Israel
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Ashkelon , , Israel
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Haifa , , Israel
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Holon , , Israel
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Brindisi , , Italy
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Centro Bologna , , Italy
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Firenze , , Italy
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Modena , , Italy
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Palermo , , Italy
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Lorenskog , , Norway
Reseach Site
Malaga , , Spain
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Izmir , , Turkey
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Glasgow , , United Kingdom
Research Site
Nottingham , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

599

Study ID:

NCT00702065

Recruitment Status:

Completed

Sponsor:


EMD Serono

How clear is this clinincal trial information?

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