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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00702065




Registration number
NCT00702065
Ethics application status
Date submitted
19/06/2008
Date registered
20/06/2008
Date last updated
17/06/2014

Titles & IDs
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
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
Secondary ID [1] 0 0
27904
Universal Trial Number (UTN)
Trial acronym
MusiQoL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1 -

2 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score
Timepoint [1] 0 0
Month 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
599
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - New Lambton Heights
Recruitment hospital [4] 0 0
Research Site - Victoria
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- New Lambton Heights
Recruitment postcode(s) [4] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Austria
State/province [4] 0 0
Graz
Country [5] 0 0
Austria
State/province [5] 0 0
Linz
Country [6] 0 0
Austria
State/province [6] 0 0
Wien
Country [7] 0 0
France
State/province [7] 0 0
Lomme
Country [8] 0 0
France
State/province [8] 0 0
Marseille
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Wildbad
Country [10] 0 0
Germany
State/province [10] 0 0
Bochum
Country [11] 0 0
Germany
State/province [11] 0 0
München
Country [12] 0 0
Israel
State/province [12] 0 0
Afula
Country [13] 0 0
Israel
State/province [13] 0 0
Ashkelon
Country [14] 0 0
Israel
State/province [14] 0 0
Haifa
Country [15] 0 0
Israel
State/province [15] 0 0
Holon
Country [16] 0 0
Italy
State/province [16] 0 0
Brindisi
Country [17] 0 0
Italy
State/province [17] 0 0
Centro Bologna
Country [18] 0 0
Italy
State/province [18] 0 0
Firenze
Country [19] 0 0
Italy
State/province [19] 0 0
Modena
Country [20] 0 0
Italy
State/province [20] 0 0
Palermo
Country [21] 0 0
Norway
State/province [21] 0 0
Lorenskog
Country [22] 0 0
Spain
State/province [22] 0 0
Malaga
Country [23] 0 0
Turkey
State/province [23] 0 0
Izmir
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Glasgow
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00702065
Trial related presentations / publications
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
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 observational study. 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): 13-16 October 2010, Gothenburg, Sweden; P650
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 Annual ISPOR Annual European Congress: November 2010, Prague, Czech Republic; P25667
Baumstarck K, Pelletier J, Boucekine M, Auquier P; MusiQoL study group. Predictors of quality of life in patients with relapsing-remitting multiple sclerosis: a 2-year longitudinal study. Rev Neurol (Paris). 2015 Feb;171(2):173-80. doi: 10.1016/j.neurol.2014.09.005. Epub 2015 Jan 2.
Boucekine M, Loundou A, Baumstarck K, Minaya-Flores P, Pelletier J, Ghattas B, Auquier P. Using the random forest method to detect a response shift in the quality of life of multiple sclerosis patients: a cohort study. BMC Med Res Methodol. 2013 Feb 15;13:20. doi: 10.1186/1471-2288-13-20.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00702065