Treatment of Post-poliomyelitis Syndrome by Intravenous I... | NCT04004390

Studies
Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin

NCT04004390

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Mar 10, 2020Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Post-Poliomyélitis Syndrom

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2019Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 30, 2019Actual

First Submitted Date

Jun 28, 2019

First Submission Date that Met QC Criteria

Jun 28, 2019

First Posted Date

Jul 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital

Detailed Description

Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation.

Collection of data retrospectively.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscular strength	Muscular strength with isokinetic	5 months

Secondary Outcomes

Measure	Description	Time Frame
Walking perimeter	Walking perimeter with walking test (6 minutes)	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of PPS
Pre- and post-therapeutic evaluation carried out
Data transcribed in the computerized patient file

Exclusion Criteria:

No walking patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

15 men and 11 women with Diagnosis of PPS

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
MOIZIARD Vincent, intern	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016262	Postpoliomyelitis Syndrome

Ancestor Terms

ID	Term
D011051	Poliomyelitis
D009187	Myelitis
D002494	Central Nervous System Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided