Intravenous versus subcutaneous immunoglobulin therapy in multifocal motor neuropathy

ISRCTN	ISRCTN66618743
DOI	https://doi.org/10.1186/ISRCTN66618743
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funders	Sanquin Blood Bank (The Netherlands), Academic Medical Centre (AMC) (The Netherlands)

Submission date: 27/06/2007
Registration date: 27/06/2007
Last edited: 07/10/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr F. Eftimov
Scientific

Academic Medical Centre
Department of Neurology
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 9111
Email	f.eftimov@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Interventional crossover trial
Secondary study design	Non randomised controlled trial
Scientific title	Intravenous versus subcutaneous immunoglobulin therapy in multifocal motor neuropathy
Study acronym	ISIM
Study objectives	Subcutaneous immunoglobulin (SCIg) therapy is as effective as intravenous immunoglobulin (IVIg) therapy in maintaining muscle strength in patients with Multifocal Motor Neuropathy (MMN).
Ethics approval(s)	Ethics approval received from the local medical ethics committee (Medisch Ethische Commissie) on the 3rd May 2007 (ref: MEC 07/101 # 07.17.0662).
Health condition(s) or problem(s) studied	Intravenous or subcutaneous immunoglobulin therapy, multifocal motor neuropathy
Intervention	Patients already treated with (different) intravenous immunoglobulin will switch to weekly subcutaneous immunoglobulin (Gammaquin, Sanquin, registered in the Netherlands under RVG 16941). This treatment will be continued for six months. After reaching the end of the study patients are allowed to choose between both treatments which they will continue.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Subcutaneous immunoglobulin (Gammaquin)
Primary outcome measure(s)	Primary outcome is maintaining the muscle strength after switching to subcutaneous immunoglobulin measured according to the Medical Research Council scale (MRC score). The MRC score will be measured during baseline visits (between two consecutive intravenous immunoglobulin treatment). After the switch to subcutaneous immunoglobulin MRC score is determined at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months.
Key secondary outcome measure(s)	1. Grip strength, measured at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months 2. Functional dexterity test, measured at 3 months and at 6 months 3. Amsterdam Linear Disability Scale (ALDS), measured at 3 months and at 6 months 4. Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale, measured at 3 months and at 6 months 5. 36-item Short Form health survey (SF-36), measured at 3 months and at 6 months 6. Modified Life Quality index, measured at 3 months and at 6 months 7. Any adverse event or reaction, measured at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months 8. Immunoglobulin G (IgG) and IgG subclass peak and trough levels, measured at 1, 2, 3, 4, 6 weeks and 3, 4 and 6 months
Completion date	01/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	10
Key inclusion criteria	1. All adult patients (greater than 18 years) with signs and symptoms consistent with MMN that fulfill the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria for definite MMN and are being treated with IVIg for at least six months at regular intervals of at most six weeks 2. Patients have to have stable disease for at least six months before inclusion
Key exclusion criteria	1. Use of drugs which are known to cause motor neuropathy 2. Patient and/or partner is/are unable to administer SCIg at home 3. Other diseases known to cause neuropathy or to reduce mobility 4. Diseases known to lead to severe handicap or death at short notice 5. A known selective Immunoglobulin A (IgA) deficiency with anti-IgA antibodies 6. Refusal to give informed consent or withdrawal of previously given permission 7. Legally incompetent adult
Date of first enrolment	01/06/2007
Date of final enrolment	01/06/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

07/10/2021: Added link to thesis.