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Clinical Trials/EUCTR2020-000067-23-GB
EUCTR2020-000067-23-GB
Active, not recruiting
Phase 1

First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients

Polyneuron Pharmaceuticals AG0 sites48 target enrollmentMarch 11, 2020
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Conditionsanti-MAG neuropathyMedDRA version: 21.1Level: LLTClassification code 10066137Term: Anti-MAG neuropathySystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
anti-MAG neuropathy
Sponsor
Polyneuron Pharmaceuticals AG
Enrollment
48
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 11, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Age between 18 and 80 years, male and female.
  • •Patient with a confirmed diagnosis of monoclonal IgM associated with monoclonal gammopathy of undetermined significance (MGUS) with anti\-MAG activity (titer of \> 10’000 Bühlmann Titer units (BTU) and demyelinating neuropathy defined by electrophysiological criteria according to European Federation of Neurological Societies/Peripheral Nervous System paraproteinemic demyelinating neuropathy EFNS/PNS PDN guideline, 2010\.
  • •Clear clinical signs of disability: with at least ONLS \= 2 in lower extremities.
  • •Inflammatory Neuropathy Cause and Treatment sensory sum score (ISS) \=2\.
  • •Adequate hepatic and renal function
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Patients with total serum IgM levels \>30 g.
  • •Hematological malignancy, prior malignancy of any organ system (except BCC)
  • •Previous immunosuppressive treatment with intravenous immunoglobulin (IVIG) or apheresis/plasmapheresis in the preceeding 3 months, and cyclophosphamide and/or biologicals (e.g. rituximab): in the preceeding 6 months prior to enrolment
  • •Other neurological, neuromuscular, rheumatologic or orthopedic conditions with significant impact on the capability of walking preventing evaluation of neurological scores

Outcomes

Primary Outcomes

Not specified

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