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 has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00702065
First received: June 19, 2008
Last updated: June 16, 2014
Last verified: June 2014
  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

Study Type: Observational
Study Design: Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Enrollment: 599
Study Start Date: November 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)

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 (inclusive, at time of informed consent).
  3. Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 30 Study Locations
Sponsors and Collaborators
EMD Serono
  More Information

No publications provided by EMD Serono

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00702065     History of Changes
Other Study ID Numbers: 27904
Study First Received: June 19, 2008
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Multiple Sclerosis Quality of life

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014