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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00702065 |
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.
Condition |
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Multiple Sclerosis |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | 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 |
Estimated Enrollment: | 570 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | September 2010 |
Groups/Cohorts |
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1 |
2 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Primary Care Clinic
Inclusion Criteria:
Patient is able to fill in the questionnaire by him/herself
Exclusion Criteria:
United States, Arizona | |
Research Site | |
Phoenix, Arizona, United States | |
United States, Nevada | |
Research Site | |
Las Vegas, Nevada, United States | |
Argentina | |
Research Site | |
Ciudad Autonoma de Buenos Aires, Argentina | |
Australia | |
Research Site | |
Melbourne, Australia | |
Research Site | |
Victoria, Australia | |
Research Site | |
Camperdown, Australia | |
Israel | |
Research Site | |
Haifa, Israel | |
Research Site | |
Holon, Israel | |
Research Site | |
Afula, Israel | |
Research Site | |
Ashkelon, Israel | |
Italy | |
Research Site | |
Centro Bologna, Italy | |
Research Site | |
Modena, Italy | |
Research Site | |
Firenze, Italy | |
Research Site | |
Palermo, Italy | |
Research Site | |
Napoli, Italy | |
Research Site | |
Brindisi, Italy | |
Norway | |
Research Site | |
Lorenskog, Norway | |
Spain | |
Reseach Site | |
Malaga, Spain | |
Turkey | |
Research Site | |
Izmir, Turkey | |
United Kingdom | |
Research Site | |
Nottingham, United Kingdom | |
Research Site | |
Glasgow, United Kingdom |
Responsible Party: | EMD Serono ( Stephanie Ruhl, Clinical Trial Manager ) |
Study ID Numbers: | 27904 |
Study First Received: | June 19, 2008 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00702065 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple Sclerosis Quality of life |
Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Quality of Life |
Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Autoimmune Diseases of the Nervous System |