Multifocal Motor Neuropathy (MMN) MedDRA version: 18.1 Level: PT Classification code 10064135 Term: Polyneuropathy chronic System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
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
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Secondary Objective: To assess the safety and tolerability of HyQvia in patients with MMN;Primary end point(s): Changes in muscle strength during treatment with HyQvia vs Subcuviaevaluated by isometric dynamometry. ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark
Contacts
Public ContactAli Al-Zuhairy
Rigshospitalet - Department of Neurology
Outcome results
None listed