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

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: HyQvia
human immunoglobulin and one vial of recombinant human hyaluronidase (rHuPH20
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Drug: rHuPH20
human immunoglobulin and one vial of recombinant human hyaluronidase
Other Name: HyQvia |
- Safety measured by anamnesis [ Time Frame: 1 year ]presence of headache, gastrointestinal complaints, fatigue, flue-like symptoms
- Quality of life (QoL) measured by a VAS questionnaire [ Time Frame: 1 year ]VAS questionnaire every visit at the outpatient clinic.
- 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
- Safety measured by questionnaire [ Time Frame: 1 year ]QoL questionnaire measured in a VAS number
- Safety measured by blood test [ Time Frame: 1 year ]Liver tests and blood counts

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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 |
Inclusion Criteria:
- Age at onset of MMN, 18 - 99 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 IVIG according to criteria that were described in previous studies.
- Stable on IVIG maintenance treatment in the year 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.
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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:
- being post-menopausal,
- being surgically sterile,
- practising contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermicide or d) being sexually inactive.
- Age < 18 years.

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
Contact: Bas Jongbloed, drs | b.a.jongbloed-2@umcutrecht.nl |
Netherlands | |
UMCU | |
Utrecht, Utrechts, Netherlands |
Principal Investigator: | Leonard van den Berg, prof | UMCU |
Responsible Party: | L.H. van den Berg, Professor dr, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT02885259 |
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 |
Neuritis Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |