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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: EUCTR
Last refreshed on: 8 August 2016
Main ID:  EUCTR2015-000828-28-NL
Date of registration: 30/11/2015
Prospective Registration: Yes
Primary sponsor: UMC Utrecht
Public title: Immunoglobulins given under the skin to treat patients with multifocal motor neuropathy (MMN). To increase the amount of immunoglobulins, an enzyme is added that will temporarily create more space under the skin. This space is filled with immunoglobulins. By this way less infusions should be needed.
Scientific title: 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
Date of first enrolment: 26/07/2016
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000828-28
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: no Single blind: yes Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Same medicine is compared in different ways of administration (IV vs SC) and hyaluronidase is added Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Netherlands
Contacts
Name: neuromuscular clinical trial nurse    
Address:  Heidelberglaan 100 3584 CX Utrecht Netherlands
Telephone:
Email: n.degoeijen@umcutrecht.nl
Affiliation:  UMC Utrecht
Name: neuromuscular clinical trial nurse    
Address:  Heidelberglaan 100 3584 CX Utrecht Netherlands
Telephone:
Email: n.degoeijen@umcutrecht.nl
Affiliation:  UMC Utrecht
Key inclusion & exclusion criteria
Inclusion criteria:
(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

Exclusion criteria:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Hyqvia
Product Name: Hyqvia
Pharmaceutical Form: Concentrate for solution for injection/infusion

Primary Outcome(s)
Main Objective: Test safety/tolerance of Hyqvia compared to IVIg
Primary end point(s): Test safety/tolerance of Hyqvia compared to IVIg
Secondary Objective: Test non-inferiority of Hyqvia compared to IVIg
Timepoint(s) of evaluation of this end point: Final timepoint :After around 9 months usage of Hyqvia per patient.
In total eight visits of the outpatient clinic will be organized to monitor safety. In case of intolerability as described in the protocol the patient can be re-switsched to IVIg.
Secondary Outcome(s)
Secondary end point(s): Test non-inferiority of Hyqvia compared to IVIg.
Timepoint(s) of evaluation of this end point: Final timepoint :After around 9 months usage of Hyqvia per patient.
In total eight visits of the outpatient clinic will be organized to monitor non-inferiority. In case of clinical deterioration as described in the protocol the patient can be re-switsched to IVIg.
Secondary ID(s)
52642
Source(s) of Monetary Support
Baxter
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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