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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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 Multifoca

Brief 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).

Detailed Summary: 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.
Sponsor: Johannes Jakobsen

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

Measurement of isometric muscle strength of four involved muscle groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in disability score [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Disability are evaluated by the use of Guy´s Neurological Disability Scale
  • Changes in clinical evaluation of muscle strength [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    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)
  • Development of Headache and Nausea [ Time Frame: During the entire study period ]
    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.
  • Development of hemolytic anemia [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Blood samples are drawn at every visit and are analyzed for hemoglobin and related parameters
  • Development of antibody against hyaluronidase [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Blood analyzed for specific antibodies against hyaluronidase
  • Patient satisfaction [ Time Frame: Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48 ]
    Patient are asked predefined question about satisfaction with the two treatment regimens and score them on a Visual Analogue Scale from 0-100 mm
  • Changes in grip strength [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Grip strength measured by Jamar® Hand dynamometer
  • Changes in hand/finger function [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    9-hole peg test. Standardized test of hand/finger function.
  • Changes in gait performance [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    40 meter walk test. Standardized test of walking performance.


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: September 18, 2015
Date Started: June 2016
Date Completion: December 2017
Last Updated: October 24, 2016
Last Verified: October 2016