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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02494505
Other study ID # P110148
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 18, 2013
Est. completion date May 9, 2018

Study information

Verified date March 2019
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective is to study if the mycophenolate could decrease the proportion of patients who relapse during the IVIG tapering period and after the IVIG withdrawal.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mycophenolate Mofetil
2g/day per os
placebo


Locations

Country Name City State
France Neurology - pitié salpetrière hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary occurrence of a relapse during the tapering off period occurrence of a relapse during the tapering off period (up to 18 months after baseline) or after the withdrawal during the monitoring period.
(the withdrawal is defined by the ability to reach the last day of IVIG treatment)
up to 18 months
Secondary Proportion of withdrew patients 6 months after the withdrawal
Secondary Proportion of withdrew patients at the end of the study 24 months
Secondary Sparing treatment (composite criteria) extension of the mean interval between IVIG courses at month 12 and month 24 compared to baseline, reduction of the total cumulative dose of IVIG at month 12 and month 24 in the mycophenolate group 24 months
Secondary Time to reach the withdrawal 24 months
Secondary EVA pain score 12 months
Secondary EVA pain score 24 months
Secondary ONLS scale 12 months
Secondary ONLS scale 24 months
Secondary R-ODS scale 12 months
Secondary R-ODS scale 24 months
Secondary MRC scale 12 months
Secondary MRC scale 24 months
Secondary INCAT sensory test 12 months
Secondary INCAT sensory test 24 months
Secondary 10 meters test 12 months
Secondary 10 meters test 24 months
Secondary SF-36 Quality of life scale 12 months
Secondary SF-36 Quality of life scale 24 months
Secondary Nottingham scale Quality of life scale 12 months
Secondary Nottingham scale Quality of life scale 24 months
Secondary global cost Comparison of the global cost in each group 24 months