NCT02556437

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

September 18, 2015

Last Update Submit

May 14, 2018

Conditions

Multifocal Motor Neuropathy

Keywords

Subcutaneous immunoglobulinMMN

Outcome Measures

Primary Outcomes (1)

  • Changes in isometric muscle strength

    Measurement of isometric muscle strength of four involved muscle groups

    Evaluation at week 0, 12, 24, 36, 48

Secondary Outcomes (9)

  • Changes in disability score

    Evaluation at week 0, 12, 24, 36, 48

  • Changes in clinical evaluation of muscle strength

    Evaluation at week 0, 12, 24, 36, 48

  • Development of Headache and Nausea

    During the entire study period

  • Development of hemolytic anemia

    Evaluation at week 0, 12, 24, 36, 48

  • Development of antibody against hyaluronidase

    Evaluation at week 0, 12, 24, 36, 48

  • +4 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia

Drug: HyQviaDrug: Subcuvia

Group B

EXPERIMENTAL

24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia)

Drug: HyQviaDrug: Subcuvia

Interventions

HyQviaDRUG

Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection

Also known as: Human immunoglobulin
Group AGroup B
SubcuviaDRUG

Human immunoglobulin 16% for subcutaneous injection

Also known as: Human immunoglobulin
Group AGroup B

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Department of Neurology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Johannes Jakobsen, DMSc

    Neuroscience Center, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 22, 2015

Study Start

June 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

DK(2)