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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02556437
Date of registration: 18/09/2015
Prospective Registration: Yes
Primary sponsor: Johannes Jakobsen
Public title: Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)
Scientific title: Randomized, Single-blind, 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: June 2016
Target sample size: 18
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02556437
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Denmark
Contacts
Name:     Johannes Jakobsen, DMSc
Address: 
Telephone:
Email:
Affiliation:  Neuroscience Center, Rigshospitalet
Key inclusion & exclusion criteria

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understanding that consent may be withdrawn at any time without prejudice.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, 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)
practising contraception with an oral contraceptive, intra-uterine device, diaphragm
or condom with spermicide or d) being sexually inactive.

- Age < 18 years



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multifocal Motor Neuropathy
Intervention(s)
Drug: HyQvia
Drug: Subcuvia
Primary Outcome(s)
Changes in isometric muscle strength [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Secondary Outcome(s)
Changes in clinical evaluation of muscle strength [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Changes in disability score [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Changes in gait performance [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Changes in grip strength [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Changes in hand/finger function [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Development of antibody against hyaluronidase [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Development of Headache and Nausea [Time Frame: During the entire study period]
Development of hemolytic anemia [Time Frame: Evaluation at week 0, 12, 24, 36, 48]
Patient satisfaction [Time Frame: Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48]
Secondary ID(s)
RH-2015-200
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Baxter Healthcare Corporation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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