Multifocal Motor NeuropathyPhase 2NCT00268788
Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
A Phase 2 study testing Subcutaneous immunoglobulin and Intravenous immunoglobulin in people with Multifocal Motor Neuropathy, run by University of Aarhus at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multifocal Motor Neuropathy
- What is being tested?
- Subcutaneous immunoglobulin and Intravenous immunoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2005to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings
Who cannot join
- Other severe medical conditions
- Pregnancy and lactation
- Anti-coagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
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
Read the 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.
- Conditions
- Multifocal Motor Neuropathy
- Being tested
- Subcutaneous immunoglobulin, Intravenous immunoglobulin
- Keywords
- multifocal motor neuropathy, subcutaneous, IVIG, gammaglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous immunoglobulinDrug
Also called Subcuvia
Individually dosed, given twice a week.
Intravenous immunoglobulinDrug
Also called Endobulin
Individual dose and frequency
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subcutaneous Ig given twice a week. Receives: Drug: Subcutaneous immunoglobulin |
| 2 | Active comparator | Intravenous Ig Receives: Drug: Intravenous immunoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic muscle strength at the three most affected muscle groups.
Measured: At the end of each arm of the crossover study
Secondary outcomes (6)
Medical research council score (MRC-score),
Measured: At the end of each treatment arm of the crossover study
9-hole peg test,
Measured: At the end of each treatment arm of the crossover study
10m walking,
Measured: At the end of each treatment arm of the crossover study
Nerve conduction parameters,
Measured: At the end of each treatment arm of the crossover study
SF-36
Measured: At the end of each treatment arm of the crossover study
Adverse effects
Measured: During each treatment arm of the crossover study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startAug 2005
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multifocal Motor NeuropathyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Henning Andersen, MD, DMSc, Principal investigator, Aarhus University HospitalJohannes Jakobsen, Professor, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268788
- Sponsor's protocol ID
- 2005-130
- Other IDs
- EudraCT-number: 2005-000934-19
- Status last verified
- Feb 2008
- First submitted
- 21 Dec 2005
- Last updated
- 21 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19236457
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Cross-Over Trial of Subcutaneous Versus Intravenous Immunoglobulin for Multifocal Motor Neuropathy
- ClinicalTrials.gov ID
- NCT00268788
- Acronym / sponsor ID
- 2005-130
- Conditions
- Multifocal Motor Neuropathy
- Keywords
- multifocal motor neuropathy, subcutaneous, IVIG, gammaglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Subcutaneous immunoglobulinSubcutaneous Ig given twice a week. |
| 2 | Active comparator | Drug: Intravenous immunoglobulinIntravenous Ig |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of multifocal motor neuropathy, supported by electrophysiological findings
Key exclusion criteria (3 listed)
- Other severe medical conditions
- Pregnancy and lactation
- Anti-coagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous immunoglobulinAlso: SubcuviaIndividually dosed, given twice a week. | Drug | 1 |
| Intravenous immunoglobulinAlso: EndobulinIndividual dose and frequency | Drug | 2 |
Primary outcome
Isokinetic muscle strength at the three most affected muscle groups.
Time frame: At the end of each arm of the crossover study
6 secondary outcomes
Medical research council score (MRC-score),
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
10m walking,
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
Adverse effects
Time frame: During each treatment arm of the crossover study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2008.
- Derived from this study: PubMed 19236457Harbo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henning Andersen, MD, DMSc principal investigator
Aarhus University Hospital
Johannes Jakobsen, Professor study chair
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Subcutaneous immunoglobulin and Intravenous immunoglobulin in people with Multifocal Motor Neuropathy, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic muscle strength at the three most affected muscle groups. (time frame: At the end of each arm of the crossover study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00268788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2008.