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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: 5 September 2016
Main ID:  NCT02885259
Date of registration: 25/01/2016
Prospective Registration: Yes
Primary sponsor: UMC Utrecht
Public title: HyQvia in Multifocal Motor Neuropathy HYMMNE
Scientific title: Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy
Date of first enrolment: September 2016
Target sample size: 20
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT02885259
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
Netherlands
Contacts
Name:     Bas Jongbloed, drs
Address: 
Telephone:
Email: b.a.jongbloed-2@umcutrecht.nl
Affiliation: 
Name:     Leonard van den Berg, prof
Address: 
Telephone:
Email:
Affiliation:  UMCU
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age at onset of MMN, 18 - 99 years.

2. The presence of asymmetrical limb weakness at onset or motor involvement having a
motor nerve distribution in at least two peripheral nerve distributions, predominant
upper limb involvement, disabling weakness MRC grade 4 or less in at least one
muscle.

3. Decreased or absent tendon reflexes in affected limbs.

4. Electrophysiological evidence of one site with definite motor conduction block or one
site with probable conduction block according to previously defined criteria.

5. Response to IVIG according to criteria that were described in previous studies.

6. Stable on IVIG maintenance treatment in the year preceding the study.

7. Patients have given written informed consent, prior to the study, with the
understanding that consent may be withdrawn at any time without prejudice.

Exclusion Criteria:

1. Bulbar signs or symptoms.

2. Upper motor neuron signs (spasticity, hyperreflexia, extensor plantar response).

3. Sensory symptoms and signs with sensory deficits on examination (except for vibration
sense) and abnormal results of sensory nerve conduction studies

4. Other neuropathies (e.g. diabetic, lead, porphyric or vasculitic neuropathy, chronic
inflammatory demyelinating polyneuropathy, Lyme neuroborreliosis, post radiation
neuropathy, hereditary neuropathy with liability to pressure palsies,
Charcot-Marie-Tooth neuropathies, meningeal carcinomatosis).

5. Treatment with other immunosuppressive drugs (cyclophosphamide, azathioprine,
cyclosporin) in the 6 months preceding the study.

6. Female patient who is pregnant or breast-feeding or of childbearing potential.

Confirmation that the patient is not pregnant will be established by a negative b-HCG
test within a 7-day period before inclusion in the study. Lack of childbearing
potential is met by:

1. being post-menopausal,

2. being surgically sterile,

3. practising contraception with an oral contraceptive, intra-uterine device,
diaphragm or condom with spermicide or d) being sexually inactive.

7. Age < 18 years.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Multifocal Motor Neuropathy
Intervention(s)
Drug: rHuPH20
Primary Outcome(s)
Safety measured by anamnesis [Time Frame: 1 year]
Secondary Outcome(s)
Quality of life (QoL) measured by a VAS questionnaire [Time Frame: 1 year]
Safety measured by blood test [Time Frame: 1 year]
Safety measured by questionnaire [Time Frame: 1 year]
Stability of muscle strength [Time Frame: 1 year]
Secondary ID(s)
NL52642.041.15
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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