Subcutaneous immunoglobulin (SCIG) and recombinant human hyaluronidase (rHuPH20) will be
tested in patient witch MMN and currently under maintenance treatment with IVIG for safety,
tolerability and efficacy.
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Locations near you
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Full eligibility criteria for NCT02885259
Ages eligible for Study
18 Years to 99 Years
Genders eligible for Study
Accepts Healthy Volunteers
Age at onset of MMN, 18 - 99 years.
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.
Decreased or absent tendon reflexes in affected limbs.
Electrophysiological evidence of one site with definite motor conduction block or one site with probable conduction block according to previously defined criteria.
Response to IVIG according to criteria that were described in previous studies.
Stable on IVIG maintenance treatment in the year preceding the study.
Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.
Bulbar signs or symptoms.
Upper motor neuron signs (spasticity, hyperreflexia, extensor plantar response).
Sensory symptoms and signs with sensory deficits on examination (except for vibration sense) and abnormal results of sensory nerve conduction studies
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).
Treatment with other immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporin) in the 6 months preceding the study.
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:
being surgically sterile,
practising contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermicide or d) being sexually inactive.
Age < 18 years.
All locations for NCT02885259
Utrecht, Utrechts, Netherlands
View full eligibility
Tris trial is registered with FDA with number: NCT02885259. The sponsor of the trial is UMC Utrecht and it is looking for 20 volunteers for the current phase.
Official trial title: Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy
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