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Multifocal Motor NeuropathyPhase 2NCT02556437

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

A Phase 2 study testing HyQvia and Subcuvia in people with Multifocal Motor Neuropathy, run by Johannes Jakobsen at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Multifocal Motor Neuropathy
What is being tested?
HyQvia and Subcuvia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesDenmark
Study dates
Jun 2016to May 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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  • Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Department of Neurology, Aarhus University Hospital

    Aarhus C, 8000

  • Department of Neurology, Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

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

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).

Read the detailed 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.

Being tested
HyQvia, Subcuvia
Keywords
Subcutaneous immunoglobulin, MMN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HyQviaDrug

    Also called Human immunoglobulin

    Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection

  • SubcuviaDrug

    Also called Human immunoglobulin

    Human immunoglobulin 16% for subcutaneous injection

Study groups in NCT02556437
Study groupRoleWhat they receive
Group AExperimental24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia
Receives: Drug: HyQvia; Drug: Subcuvia
Group BExperimental24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia)
Receives: Drug: HyQvia; Drug: Subcuvia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in isometric muscle strength

    Measurement of isometric muscle strength of four involved muscle groups

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

Secondary outcomes (9)

  1. Changes in disability score

    Disability are evaluated by the use of Guy´s Neurological Disability Scale

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

  2. 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)

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

  3. 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.

    Measured: During the entire study period

  4. Development of hemolytic anemia

    Blood samples are drawn at every visit and are analyzed for hemoglobin and related parameters

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

  5. Development of antibody against hyaluronidase

    Blood analyzed for specific antibodies against hyaluronidase

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

  6. 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

    Measured: Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48

  7. Changes in grip strength

    Grip strength measured by Jamar® Hand dynamometer

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

  8. Changes in hand/finger function

    9-hole peg test. Standardized test of hand/finger function.

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

  9. Changes in gait performance

    40 meter walk test. Standardized test of walking performance.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2018
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02556437
Sponsor's protocol ID
RH-2015-200
Status last verified
May 2018
First submitted
18 Sep 2015
Last updated
17 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HyQvia and Subcuvia in people with Multifocal Motor Neuropathy, run by Johannes Jakobsen at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in isometric muscle strength (time frame: Evaluation at week 0, 12, 24, 36, 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556437.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.

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