NCT00949065

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2011

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

1.4 years

First QC Date

July 29, 2009

Last Update Submit

July 8, 2021

Conditions

Complex Regional Pain Syndrome Type 1

Keywords

complex regional pain syndromesympathetic reflex dystrophyintravenous immunoglobulinsautoimmune disease

Outcome Measures

Primary Outcomes (1)

  • Change in impairment Level SumScore (ISS)

    after 0,3,6,9 months

Secondary Outcomes (4)

  • 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

    0,3,6,9 months

  • Serum concentration of B-cell activating factors BAFF, APRIL

    0,3,6,9 months

Study Arms (2)

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

intravenous immunoglobulinsBIOLOGICAL

0.36-0.44g/Kg IvIg intravenous, 3x, every 4 weeks

Also known as: Gamunex 10%
Intravenous immunoglobulins (IvIg)NaCl 0.9%

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the Justus-Liebig-University

Giessen, Hesse, 35392, Germany

Location

Related Publications (2)

  • 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.

    PMID: 19375222BACKGROUND

  • Goebel A, Stock M, Deacon R, Sprotte G, Vincent A. Intravenous immunoglobulin response and evidence for pathogenic antibodies in a case of complex regional pain syndrome 1. Ann Neurol. 2005 Mar;57(3):463-4. doi: 10.1002/ana.20400. No abstract available.

    PMID: 15732112BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain SyndromesReflex Sympathetic DystrophyAutoimmune Diseases

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

August 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 15, 2011

Last Updated

July 15, 2021

Record last verified: 2021-07

Locations

DE(1)