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HyQvia in Multifocal Motor Neuropathy (HYMMNE)

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ClinicalTrials.gov Identifier: NCT02885259
Recruitment Status : Unknown
Verified August 2016 by L.H. van den Berg, UMC Utrecht.
Recruitment status was:  Not yet recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
L.H. van den Berg, UMC Utrecht

Study Description
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Brief Summary:
Subcutaneous immunoglobulin (SCIG) and recombinant human hyaluronidase (rHuPH20) will be tested in patient witch MMN and currently under maintenance treatment with IVIG for safety, tolerability and efficacy.

Condition or disease Intervention/treatment Phase
Multifocal Motor Neuropathy Drug: rHuPH20 Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous Immunoglobulin With rHuPH20 in Multifocal Motor Neuropathy
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HyQvia
human immunoglobulin and one vial of recombinant human hyaluronidase (rHuPH20
 Drug: rHuPH20
human immunoglobulin and one vial of recombinant human hyaluronidase
Other Name: HyQvia


Outcome Measures
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Primary Outcome Measures :
  1. Safety measured by anamnesis [ Time Frame: 1 year ]
    presence of headache, gastrointestinal complaints, fatigue, flue-like symptoms


Secondary Outcome Measures :
  1. Quality of life (QoL) measured by a VAS questionnaire [ Time Frame: 1 year ]
    VAS questionnaire every visit at the outpatient clinic.

  2. Stability of muscle strength [ Time Frame: 1 year ]
    Every visit at the outpatient clinic a Guy's neurologic disability scale (GNDS) and MRC sum score are obtained

  3. Safety measured by questionnaire [ Time Frame: 1 year ]
    QoL questionnaire measured in a VAS number

  4. Safety measured by blood test [ Time Frame: 1 year ]
    Liver tests and blood counts


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at onset of MMN, 18 - 99 years.
  2. 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.
  3. Decreased or absent tendon reflexes in affected limbs.
  4. Electrophysiological evidence of one site with definite motor conduction block or one site with probable conduction block according to previously defined criteria.
  5. Response to IVIG according to criteria that were described in previous studies.
  6. Stable on IVIG maintenance treatment in the year preceding the study.
  7. 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:

  1. Bulbar signs or symptoms.
  2. Upper motor neuron signs (spasticity, hyperreflexia, extensor plantar response).
  3. Sensory symptoms and signs with sensory deficits on examination (except for vibration sense) and abnormal results of sensory nerve conduction studies
  4. 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).
  5. Treatment with other immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporin) in the 6 months preceding the study.

  6. 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:

    1. being post-menopausal,
    2. being surgically sterile,
    3. practising contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermicide or d) being sexually inactive.
  7. Age < 18 years.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885259


Contacts
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Contact: Bas Jongbloed, drs b.a.jongbloed-2@umcutrecht.nl

Locations
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Netherlands
UMCU
Utrecht, Utrechts, Netherlands
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Leonard van den Berg, prof UMCU
More Information
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Responsible Party: L.H. van den Berg, Professor dr, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02885259     History of Changes
Other Study ID Numbers: NL52642.041.15
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs