NCT00268788

Brief Summary

The purpose of this study is to evaluate the effect of subcutaneous administration of immunoglobulin compared to intravenous treatment, for multifocal motor neuropathy NB. ONLY RECRUITING FROM DENMARK

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

February 21, 2008

Status Verified

February 1, 2008

Enrollment Period

2.5 years

First QC Date

December 21, 2005

Last Update Submit

February 19, 2008

Conditions

Multifocal Motor Neuropathy

Keywords

multifocal motor neuropathysubcutaneousIVIGgammaglobulin

Outcome Measures

Primary Outcomes (1)

  • Isokinetic muscle strength at the three most affected muscle groups.

    At the end of each arm of the crossover study

Secondary Outcomes (6)

  • Medical research council score (MRC-score),

    At the end of each treatment arm of the crossover study

  • 9-hole peg test,

    At the end of each treatment arm of the crossover study

  • 10m walking,

    At the end of each treatment arm of the crossover study

  • Nerve conduction parameters,

    At the end of each treatment arm of the crossover study

  • SF-36

    At the end of each treatment arm of the crossover study

  • +1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Subcutaneous Ig given twice a week.

Drug: Subcutaneous immunoglobulin

2

ACTIVE COMPARATOR

Intravenous Ig

Drug: Intravenous immunoglobulin

Interventions

Subcutaneous immunoglobulinDRUG

Individually dosed, given twice a week.

Also known as: Subcuvia
1
Intravenous immunoglobulinDRUG

Individual dose and frequency

Also known as: Endobulin
2

Eligibility Criteria

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

You may qualify if:

  • \- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings

You may not qualify if:

  • Other severe medical conditions
  • Pregnancy and lactation
  • Anti-coagulation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Neyrology

Aarhus, Denmark

Location

Related Publications (1)

  • Harbo T, Andersen H, Hess A, Hansen K, Sindrup SH, Jakobsen J. Subcutaneous versus intravenous immunoglobulin in multifocal motor neuropathy: a randomized, single-blinded cross-over trial. Eur J Neurol. 2009 May;16(5):631-8. doi: 10.1111/j.1468-1331.2009.02568.x. Epub 2009 Feb 19.

    PMID: 19236457DERIVED

MeSH Terms

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Henning Andersen, MD, DMSc

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Johannes Jakobsen, Professor

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 22, 2005

Study Start

August 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 21, 2008

Record last verified: 2008-02

Locations

DK(1)