Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

• 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
• 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understanding that consent may be withdrawn at any time without prejudice.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: Subcuvia

Drug: HyQvia

Primary Outcome(s)

Changes in isometric muscle strength [Time Frame: Evaluation at week 0, 12, 24, 36, 48]

Secondary Outcome(s)

Patient satisfaction [Time Frame: Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48]

Changes in clinical evaluation of muscle 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]

Changes in disability score [Time Frame: Evaluation at week 0, 12, 24, 36, 48]

Changes in grip strength [Time Frame: Evaluation at week 0, 12, 24, 36, 48]

Development of Headache and Nausea [Time Frame: During the entire study period]

Development of antibody against hyaluronidase [Time Frame: Evaluation at week 0, 12, 24, 36, 48]

Development of hemolytic anemia [Time Frame: Evaluation at week 0, 12, 24, 36, 48]

Changes in gait performance [Time Frame: Evaluation at week 0, 12, 24, 36, 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