NCT00305266

Brief Summary

The aim of this study is to quantify the effect of IVIG treatment in a group of patients with chronic inflammatory demyelinating polyradiculoneuropathy(CIDP), who requires continues treatment of IVIG at regular intervals of 3-10 weeks:

  1. 1.During continues treatment of IVIG at regular intervals of 3-10 weeks.
  2. 2.During pause in treatment.
  3. 3.The disease activity in the patients are cyclical correlating to the treatment intervals.
  4. 4.Pause in treatment will increase disease activity, which can be quantified with symptom scores, disability scales, and clinical test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 3, 2007

Status Verified

November 1, 2007

First QC Date

March 20, 2006

Last Update Submit

November 30, 2007

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Keywords

CIDPIVIGgammaglobulinChronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions

intravenous gammaglobulinDRUG

individual dose

Eligibility Criteria

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

You may qualify if:

  • Motor and sensory dysfunction involving more than one limb.
  • Electrodiagnostic study with signs of demyelination

You may not qualify if:

  • Prior systemic allergic reaction to IVIG
  • Severe systemic disease
  • Other conditions associated with neuropathy (eg diabetes, lack of vitamin- B12)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Neurology

Aarhus, Denmark

Location

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henning Andersen, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Johannes Jakobsen, professor

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2006

First Posted

March 21, 2006

Study Start

August 1, 2005

Study Completion

August 1, 2007

Last Updated

December 3, 2007

Record last verified: 2007-11

Locations

DK(1)