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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00268788
Date of registration: 21/12/2005
Prospective Registration: Yes
Primary sponsor: University of Aarhus
Public title: Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
Scientific title: A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
Date of first enrolment: August 2005
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00268788
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Denmark
Contacts
Name:     Johannes Jakobsen, Professor
Address: 
Telephone:
Email:
Affiliation:  Aarhus University Hospital
Name:     Henning Andersen, MD, DMSc
Address: 
Telephone:
Email:
Affiliation:  Aarhus University Hospital, Aarhus, Denmark
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Multifocal Motor Neuropathy
Intervention(s)
Drug: Intravenous immunoglobulin
Drug: Subcutaneous immunoglobulin
Primary Outcome(s)
Isokinetic muscle strength at the three most affected muscle groups. [Time Frame: At the end of each arm of the crossover study]
Secondary Outcome(s)
10m walking, [Time Frame: At the end of each treatment arm of the crossover study]
9-hole peg test, [Time Frame: At the end of each treatment arm of the crossover study]
Adverse effects [Time Frame: During each treatment arm of the crossover study]
Medical research council score (MRC-score), [Time Frame: At the end of each treatment arm of the crossover study]
Nerve conduction parameters, [Time Frame: At the end of each treatment arm of the crossover study]
SF-36 [Time Frame: At the end of each treatment arm of the crossover study]
Secondary ID(s)
2005-130
EudraCT-number: 2005-000934-19
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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