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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
This study is ongoing, but not recruiting participants.
First Received: June 19, 2008   Last Updated: March 21, 2009   History of Changes
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00702065
  Purpose

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
Multiple Sclerosis

MedlinePlus related topics: Multiple Sclerosis
U.S. FDA Resources
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

Further study details as provided by EMD Serono:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 570
Study Start Date: November 2007
Estimated Study Completion Date: September 2010
Groups/Cohorts
1
2

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 and M24 in patients with MS. In addition, physical health outcomes such as expanded disability status scores (EDSS) will be collected every 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

  1. Patient has any form of MS (confirmed by McDonald and/or Poser criteria)
  2. Patient is 18* years old or more.
  3. Patient has an EDSS score lower than 7.0* (inclusive)
  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

    • inclusive, at time of informed consent

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702065

Locations
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
Sponsors and Collaborators
EMD Serono
  More Information

No publications provided

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

Keywords provided by EMD Serono:
Multiple Sclerosis Quality of life

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Quality of Life
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009