Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal M… (NCT02556437) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)
Denmark18 participantsStarted 2016-06
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin 10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment in patients with Multifocal Motor Neuropathy (MMN).
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* Age at onset 18 - 65 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 SCIG according to criteria that were described in previous studies
* On SCIG maintenance treatment for more than 3 months 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* Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.
Exclusion Criteria:
* 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, azathioprin…