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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00702065
Date of registration: 19/06/2008
Primary sponsor: EMD Serono
Public 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 MusiQoL
Scientific 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
Date of first enrolment: November 2007
Target sample size: 600
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00702065
Study type:  Observational
Study design:  Time Perspective: Prospective  
Countries of recruitment
Argentina Australia Israel Italy Norway Spain Turkey United Kingdom
United States
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
27904
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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