World Health Organization site
Skip Navigation Links

Main
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: 21 May 2018
Main ID:  EUCTR2015-003453-18-DK
Date of registration: 23/09/2015
Prospective Registration: Yes
Primary sponsor: Rigshospitalet
Public title: Study of the effect and safety of a new immunoglobulin preparation (HyQvia) for subcutaneous usage in patients with Multifocal Motor Neuropathy
Scientific title: A Randomized, Single-blinded, Cross-over Study investigating the Non-inferiority of Efficacy and Safety of HyQvia in comparison with Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy
Date of first enrolment: 25/11/2015
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003453-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Denmark
Contacts
Name: Ali Al-Zuhairy   
Address:  Blegdamsvej 9 2100 Copenhagen Denmark
Telephone: 004522981147
Email: al_zuhairy@hotmail.com
Affiliation:  Rigshospitalet - Department of Neurology
Name: Ali Al-Zuhairy   
Address:  Blegdamsvej 9 2100 Copenhagen Denmark
Telephone: 004522981147
Email: al_zuhairy@hotmail.com
Affiliation:  Rigshospitalet - Department of Neurology
Key inclusion & exclusion criteria
Inclusion criteria:
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 group.

Decreased or absent tendon reflexes in affected limbs.

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

Response to subcutaneous immunoglobulin according to criteria described in previous studies.

On subcutaneous immunoglobulin maintenance treatment prior to enrolment.

Age at onset 18-65 years.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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, 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 a) being post-menopausal, b) being surgically sterile, c) practicing contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermacide or d) being sexually inactive.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Multifocal Motor Neuropathy (MMN)
MedDRA version: 18.1 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: HyQvia
Product Name: HyQvia
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Subcuvia
Product Name: Subcuvia
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-

Primary Outcome(s)
Main Objective: To assess the efficacy of immunoglobulin administered together with hyaluronidase (HyQvia) in large doses subcutaneously compared to conventional treatment with subcutaneous immunoglobulin (Subcuvia) in patients with MMN
Primary end point(s): Changes in muscle strength during treatment with HyQvia vs Subcuviaevaluated by isometric dynamometry.
Secondary Objective: To assess the safety and tolerability of HyQvia in patients with MMN
Timepoint(s) of evaluation of this end point: Group A: 24 weeks of Subcuvia treatment followed by 24 weeks of HyQvia treatment
Timepoints for clinical examination: Week 0, 12, 24, 36 and 48
Telephone interview according to side effects and compliance: Week 6, 18, 30 and 42

Group B: 24 weeks of HyQvia treatment followed by 24 weeks of Subcuvia treatment
Timepoints for clinical examination: Week 0, 12, 24, 36 and 48
Telephone interview according to side effects and compliance: Week 6, 18, 30 and 42
Secondary Outcome(s)
Secondary end point(s): Changes in muscle strength during treatment with HyQvia vs Subcuvia evaluated by hand held dynamometry (grip strength) and clinical examination.

Changes in disability score during treatment with HyQvia vs Subcuvia, evaluated by Guy’s Neurological Disability Scale and the self-evaluation scale.

Changes in physical function and performance during treatment with HyQvia vs Subcuvia, evaluated by 9-hole-peg test and 40 meter-walk-test.

Development and severity of headache and nausea during treatment with HyQvia, evaluated by questionnaire

Development of hemolytic anemia during treatment, evaluated by blood analysis

Development of antibody against hyaluronidase during treatment with HyQvia, evaluated by blood analysis
Patient satisfaction, evaluated by questionnaire
Timepoint(s) of evaluation of this end point: Group A: 24 weeks of Subcuvia treatment followed by 24 weeks of HyQvia treatment
Timepoints for clinical examination: Week 0, 12, 24, 36 and 48
Telephone interview according to side effects and compliance: Week 6, 18, 30 and 42

Group B: 24 weeks of HyQvia treatment followed by 24 weeks of Subcuvia treatment
Timepoints for clinical examination: Week 0, 12, 24, 36 and 48
Telephone interview according to side effects and compliance: Week 6, 18, 30 and 42
Secondary ID(s)
RH-2015-200
Source(s) of Monetary Support
Rigshospitalet - Neuroscience Center
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history