Intravenous versus subcutaneous immunoglobulin therapy in multifocal motor neuropathy
| ISRCTN | ISRCTN66618743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66618743 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr F. Eftimov
Scientific
Scientific
Academic Medical Centre
Department of Neurology
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| f.eftimov@amc.uva.nl |
Study information
| Study design | Interventional crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Intravenous versus subcutaneous immunoglobulin therapy in multifocal motor neuropathy |
| Study 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(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). |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Subcutaneous immunoglobulin (Gammaquin) |
| Primary outcome measure | 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 study start date | 01/06/2007 |
| Overall study end date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 10 |
| 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 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
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Neurology
PO Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Sanquin Blood Bank (The Netherlands)
No information available
Academic Medical Centre (AMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
07/10/2021: Added link to thesis.
