Titlle: Subcutaneous immunoglobulins with rHuPH20 in multifocal motor neuropathy (MMN) It is an interventional cross-over study where the use of the combination of subcutaneous immunoglobulins together with the enzyme hyaluronidase (rHuPH20) is compared with the current gold standard intravenous immunoglobulins (IVIg). Non-inferiority and tolerability are studied in 20 MMN patients. The reason to add rHuPH20 is to increase volumes per infusion and in this way contribute to reduced frequency of infusions. - Hymne

MC Utrecht0 个研究点开始时间: 2015年11月30日最近更新: 2016年8月8日

试验速览

暂无简介。

•(1) Age at onset of MMN, 18 – 65 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 IGIV according to criteria that were described in previous studies.
•(6) stable on IGIV 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•(7) Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•(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 a) being post-menopausal, b) being surgically sterile, c) practising contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermacide or d) being sexually inactive.
•(7) Age < 18 years.

发起方

MC Utrecht