Intravenous Immunoglobulins in Complex-regional Pain Synd... | NCT00949065

Studies
Intravenous Immunoglobulins in Complex-regional Pain Syndrome

NCT00949065

Sponsor

University of Giessen

Status

Withdrawn

Last Update Posted

Jul 15, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Complex Regional Pain Syndrome Type 1

Interventions

intravenous immunoglobulins

Countries

Germany

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No more interest to follow this study

Expanded Access Info

Start Date

Aug 2009Actual

Primary Completion Date

Jan 2011Actual

Completion Date

Feb 15, 2011Actual

First Submitted Date

Jul 29, 2009

First Submission Date that Met QC Criteria

Jul 29, 2009

First Posted Date

Jul 30, 2009Estimated

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

Jul 8, 2021

Last Update Posted Date

Jul 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine whether intravenous immunoglobulins are effective in the treatment of complex-regional pain syndrome.

Detailed Description

CRPS, a chronic pain syndrome associated with trophic disturbances is a frequent complication after limb trauma. More than one third of the CRPS will continue to chronic disease including loss of function in one limb. Some reports implicate an autoimmune pathogenesis of CRPS. Especially the finding of autoantibodies against peripheral neurons and successful treatment in single cases provide evidence for a possible successful treatment of CRPS with intravenous immunoglobulins (IvIg). Therefore IvIg may be an important anti-inflammatory treatment to prevent severe chronification of CRPS. Since IvIg is mainly effective in B-cell-mediated autoimmune diseases, autoantibodies against autonomic neurons and the concentration of B-cell activating factors BAFF and APRIL will be measured in the course of the study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous immunoglobulins (IvIg)	Active Comparator	3 x 0.36-0.44g/Kg IvIg every 4 weeks, then 3 months washing out, then 3x NaCl 0.9% every 4 weeks	Biological: intravenous immunoglobulins
NaCl 0.9%	Placebo Comparator	NaCl 0.9%, 3x, every 4 weeks, then 3 months washing out, then 0.36-0.44g/Kg IvIg, 3x, every 4 weeks	Biological: intravenous immunoglobulins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravenous immunoglobulins	Biological	0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks	Intravenous immunoglobulins (IvIg) NaCl 0.9%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in impairment Level SumScore (ISS)		after 0,3,6,9 months

Secondary Outcomes

Measure	Description	Time Frame
Pain disability score		0,3,6,9 months
Quality of life (SF-36)		0,3,6,9 months
Titer of surface-binding neuronal autoantibodies in the serum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CRPS 1 (according to the IASP criteria) between 6 weeks and 6 months after diagnosis
skin temperature of the affected side equal or higher than on non-affected side
no change of the analgetic or co-analgetic medication within the last 10 days

Exclusion Criteria:

Immunosuppressive or immunomodulatory treatment within the last three months
CRPS previously treated with sympathetic block, lidocaine patch, local DMSO, spinal cord stimulation, intrathecal drug administration
Known immune-mediated neuropathy (CIDP, MMN, MADSAM)
Selective IgA-deficiency
Severe heart disease
Tumour disease in the last 5 years
Allergy against Gamunex 10%
Chronic renal disease Vaccination with live vaccine within the last three months
Member of another clinical trial within the last 3 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the Justus-Liebig-University		Giessen	Hesse	35392	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19375222	Background	Kohr D, Tschernatsch M, Schmitz K, Singh P, Kaps M, Schafer KH, Diener M, Mathies J, Matz O, Kummer W, Maihofner C, Fritz T, Birklein F, Blaes F. Autoantibodies in complex regional pain syndrome bind to a differentiation-dependent neuronal surface autoantigen. Pain. 2009 Jun;143(3):246-251. doi: 10.1016/j.pain.2009.03.009. Epub 2009 Apr 16.
15732112

ID	Term
D020918	Complex Regional Pain Syndromes
D012019	Reflex Sympathetic Dystrophy
D001327	Autoimmune Diseases

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

ID	Term
D007074	Immunoglobulin G
D007132	Immunoglobulin Isotypes
D000906	Antibodies
D007136	Immunoglobulins