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Change of Nerve Conduction Properties in IVIg Dependent Neuropathies

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ClinicalTrials.gov Identifier: NCT01655394
Recruitment Status : Unknown
Verified December 2014 by Helmar Lehmann, University of Cologne.
Recruitment status was:  Active, not recruiting
First Posted : August 1, 2012
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Helmar Lehmann, University of Cologne

Tracking Information
First Submitted Date July 30, 2012
First Posted Date August 1, 2012
Last Update Posted Date December 12, 2014
Study Start Date October 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2014)
Clinical Improvement [ Time Frame: 6 Months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01655394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
Official Title Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
Brief Summary IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.
Detailed Description IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Probability Sample
Study Population patients with immune neuropathies
Condition
  • Guillain-Barre Syndrome
  • CIDP
  • Multifocal Motor Neuropathy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 31, 2012)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • immune neuropathy
  • age above 18 y
  • IVIg treatment

exclusion:

  • no IVIg treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01655394
Other Study ID Numbers 01607831337
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Helmar Lehmann, University of Cologne
Study Sponsor University of Cologne
Collaborators Not Provided
Investigators
Principal Investigator: Helmar C. Lehmann, PD Dr. med. PI
PRS Account University of Cologne
Verification Date December 2014