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Completed

NCT Number: NCT00702065

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 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Reseach site, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Acronym: MusiQoL

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2008
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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