Condition category
Nervous System Diseases
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
04/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr F. Eftimov

ORCID ID

Contact details

Academic Medical Centre
Department of Neurology
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 9111
f.eftimov@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ISIM

Study hypothesis

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

Ethics approval received from the local medical ethics committee (Medisch Ethische Commissie) on the 3rd May 2007 (ref: MEC 07/101 # 07.17.0662).

Study design

Interventional crossover trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Subcutaneous immunoglobulin (Gammaquin)

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/06/2007

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10

Participant 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

Recruitment start date

01/06/2007

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Sanquin Blood Bank (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes