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

Multiple Sclerosis Clinical Trial

— MusiQoL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702065
• Other study ID #: 27904
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: June 16, 2014
• Start date: November 2007
• Est. completion date: October 2010

Study information

• Verified date: June 2014
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Argentina	Reseach site	Buenos Aires
Argentina	Research Site	Buenos Aires
Australia	Research Site	Camperdown
Australia	Research Site	Melbourne
Australia	Research Site	New Lambton Heights
Australia	Research Site	Victoria
Austria	Research Site	Graz
Austria	Research Site	Linz
Austria	Research Site	Wien
France	Research Site	Lomme
France	Research Site	Marseille
Germany	Research Site	Bad Wildbad
Germany	Research Site	Bochum
Germany	Research Site	München
Israel	Research Site	Afula
Israel	Research Site	Ashkelon
Israel	Research Site	Haifa
Israel	Research Site	Holon
Italy	Research Site	Brindisi
Italy	Research Site	Centro Bologna
Italy	Research Site	Firenze
Italy	Research Site	Modena
Italy	Research Site	Palermo
Norway	Research Site	Lorenskog
Spain	Reseach Site	Malaga
Turkey	Research Site	Izmir
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Nottingham
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  France,  Germany,  Israel,  Italy,  Norway,  Spain,  Turkey,  United Kingdom, 

References & Publications (3)

Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life and Short Form-36 questionnaires to Expanded Disability Status Scale score changes in subjects with multiple sclerosis: 12-month results of an international observati

Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life questionnaire to Expanded Disability Status Scale score changes in subjects with Multiple Sclerosis: Month 12 results from an international observational study. 13th

Auquier P, et al. Responsiveness of the Multiple Sclerosis International Quality of Life(MusiQoL) questionnaire to changes in disability in subjects with multiple sclerosis: 12-month results. Eur J Neurol 2010;17(Suppl 3):486

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score		Month 24	No