HyQvia in Multifocal Motor Neuropathy

NCT02885259 | Unknown DMC

• 1 other identifier: NL52642.041.15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multifocal Motor Neuropathy

Outcome Measures

Primary Outcomes (1)

• Safety measured by anamnesis

  presence of headache, gastrointestinal complaints, fatigue, flue-like symptoms

  1 year

Secondary Outcomes (4)

• Quality of life (QoL) measured by a VAS questionnaire

  1 year

• Stability of muscle strength

  1 year

• Safety measured by questionnaire

  1 year

• Safety measured by blood test

  1 year

Study Arms (1)

HyQvia

EXPERIMENTAL

human immunoglobulin and one vial of recombinant human hyaluronidase (rHuPH20

Drug: rHuPH20

Interventions

rHuPH20 DRUG

human immunoglobulin and one vial of recombinant human hyaluronidase

Also known as: HyQvia

HyQvia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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• Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.

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.
• 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.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMCU

Utrecht, Utrechts, Netherlands

Location

Study Officials

• Leonard van den Berg, prof

  UMCU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bas Jongbloed, drs

CONTACT

b.a.jongbloed-2@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)