Status:
COMPLETED
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
Lead Sponsor:
EMD Serono
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Brief 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 a...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT00702065
Start Date
November 1 2007
End Date
October 1 2010
Last Update
June 17 2014
Active Locations (30)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Las Vegas, Nevada, United States
3
Reseach site
Buenos Aires, Argentina
4
Research Site
Buenos Aires, Argentina