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

Multifocal Motor Neuropathy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556437
• Other study ID #: RH-2015-200
• Status: Completed
• Phase: Phase 2
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin 10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment in patients with Multifocal Motor Neuropathy (MMN).

Description:

Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to intravenous immunoglobulin (IGIV), may be self-induced and may induce fewer systemic adverse reactions. Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. This is an issue in particular in MMN where relatively high and frequent doses are necessary to maintain long-term improvement of muscle strength. Recombinant human hyaluronidase (rHuPH20) increases subcutaneous tissue permeability and facilitates dispersion and absorption, enabling subcutaneous administration of higher (monthly) doses of Ig. If treatment with HyQvia is at least equally effective and safe as compared with conventional Ig treatment, HyQvia could become the preferred treatment option for patients with MMN as it may have attractive benefits for patients by its mode of administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Multifocal Motor Neuropathy
• Neuritis

Intervention

Drug:
• HyQvia
Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection
• Subcuvia
Human immunoglobulin 16% for subcutaneous injection

Locations

Country	Name	City	State
Denmark	Department of Neurology, Aarhus University Hospital	Aarhus C
Denmark	Department of Neurology, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Jakobsen	Baxter Healthcare Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in isometric muscle strength	Measurement of isometric muscle strength of four involved muscle groups	Evaluation at week 0, 12, 24, 36, 48
Secondary	Changes in disability score	Disability are evaluated by the use of Guy´s Neurological Disability Scale	Evaluation at week 0, 12, 24, 36, 48
Secondary	Changes in clinical evaluation of muscle strength	Medical Research Council (MRC) sum score of 9 muscle groups bilateral (shoulder abduction, elbow flexion/extension, wrist flexion/extension, hip flexion, knee flexion/extension, ankle dorsal flexion)	Evaluation at week 0, 12, 24, 36, 48
Secondary	Development of Headache and Nausea	Participants are asked to register severity of headache and nausea on a VAS scale from 0-100 mm on every day of infusion and the day after.	During the entire study period
Secondary	Development of hemolytic anemia	Blood samples are drawn at every visit and are analyzed for hemoglobin and related parameters	Evaluation at week 0, 12, 24, 36, 48
Secondary	Development of antibody against hyaluronidase	Blood analyzed for specific antibodies against hyaluronidase	Evaluation at week 0, 12, 24, 36, 48
Secondary	Patient satisfaction	Patient are asked predefined question about satisfaction with the two treatment regimens and score them on a Visual Analogue Scale from 0-100 mm	Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48
Secondary	Changes in grip strength	Grip strength measured by Jamar® Hand dynamometer	Evaluation at week 0, 12, 24, 36, 48
Secondary	Changes in hand/finger function	9-hole peg test. Standardized test of hand/finger function.	Evaluation at week 0, 12, 24, 36, 48
Secondary	Changes in gait performance	40 meter walk test. Standardized test of walking performance.	Evaluation at week 0, 12, 24, 36, 48