Clinical trial NCT00268788: Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
Official title: A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multifocal Motor Neuropathy
Keywords: multifocal motor neuropathy
subcutaneous
IVIG
gammaglobulin
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: Introduction Intravenous immunoglobulin (IVIG) treatment is the only established treatment modality in Multifocal Motor Neuropathy (MMN). In order to maintain neuromuscular performance patients require lifelong treatment. Hospital-based treatments have high cost and inconveniences to patients, particularly in chronic disorders. Immunoglobulin preparations are now available for subcutaneous use as IgG replacement therapy. The safety and efficacy of subcutaneous infusion is reported to be comparable to i.v. preparations, and has been applied successfully in other autoimmune disorders. However patients with MMN have not previously been treated with subcutaneous immunoglobulin.

Hypothesis:

Subcutaneous immunoglobulin treatment is efficacious and safe with less patient inconvenience.

Primary endpoint:

Isokinetic muscle strength at the end of treatment A vs B (subcutaneous vs i.v.)

Secondary endpoint:

Medical research council score (MRC-score), 9-hole peg test, 10m walking, Nerve conduction parameters, SF-36.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Isokinetic muscle strength at the three most affected muscle groups.
timeFrame: At the end of each arm of the crossover study
Secondary outcomes:
measure: Medical research council score (MRC-score),
timeFrame: At the end of each treatment arm of the crossover study
measure: 9-hole peg test,
timeFrame: At the end of each treatment arm of the crossover study
measure: 10m walking,
timeFrame: At the end of each treatment arm of the crossover study
measure: Nerve conduction parameters,
timeFrame: At the end of each treatment arm of the crossover study
measure: SF-36
timeFrame: At the end of each treatment arm of the crossover study
measure: Adverse effects
timeFrame: During each treatment arm of the crossover study
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Neyrology
Study officials:
affiliation: Aarhus University Hospital
name: Henning Andersen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Johannes Jakobsen, Professor
role: STUDY_CHAIR
References:
citation: 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.