NCT02494505

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2018

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

4.5 years

First QC Date

June 10, 2015

Last Update Submit

March 14, 2019

Conditions

Chronic Inflammatory Demyelinating Polyradiculopathy

Keywords

chronic inflammatory demyelinating polyradiculopathyintravenous immunoglobulin (IVIG)withdrawalquality of lifeClinical trialcost

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (21)

  • Proportion of withdrew patients

    6 months after the withdrawal

  • Proportion of withdrew patients at the end of the study

    24 months

  • Sparing treatment (composite criteria)

    24 months

  • Time to reach the withdrawal

    24 months

  • EVA pain score

    12 months

  • +16 more secondary outcomes

Study Arms (2)

mycophenolate mofetil

EXPERIMENTAL
Drug: Mycophenolate Mofetil

placebo

PLACEBO COMPARATOR

placebo pills

Drug: placebo

Interventions

Mycophenolate MofetilDRUG

2g/day per os

mycophenolate mofetil
placeboDRUG
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient older than eighteen
  • Written informed consent for study participation
  • Definite or probable CIDP according to EFNS/PNS criteria or atypical CIDP (need to meet clinical EFNS/PNS criteria and at least 2 criteria among the EFNS/PNS supplementary criteria)
  • Being responder (= decrease of at least 1 point on the ONLS score after IVIG) and dependent to IVIG (= increase of at least 1 point on the ONLS score after IVIG withdrawal or during the tapering period)
  • Having received at least 3 courses of IVIG
  • Negative pregnancy test for women of child-bearing age

You may not qualify if:

  • No social security benefit
  • Pregnancy or intention to become pregnant
  • Nursing mother
  • Recent or active VIH or hepatitis B or C , or lyme infections
  • Monoclonal IgM gammapathy with anti MAG antibodies or CANOMAD syndrome
  • Neutropenia \< 1G/L
  • Patients having received Mycophenolate
  • History of allergy to mycophenolate or placebo excipient
  • Patients receiving : plasma exchange, magnesium hydroxide, aluminium hydroxide, cholestyramine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurology - pitié salpetrière hospital

Paris, 75013, France

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Karine Viala, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2015

First Posted

July 10, 2015

Study Start

November 18, 2013

Primary Completion

May 9, 2018

Study Completion

May 9, 2018

Last Updated

March 15, 2019

Record last verified: 2019-03

Locations

FR(1)