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Randomized Placebo Controlled Trial of IVIg in Glycine Receptor Antibody Positive Stiff-person Syndrome

NCT03749096 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-06-13

No results posted yet for this study

Summary

This is a randomized double-blind controlled trial of intravenous immunoglobulin (IVIg) for glycine receptor antibody positive (GlyRα1) antibody Stiff Person Syndrome (SPS) spectrum disorders. Adult patients will be enrolled over the course of 36 months. Study duration per patient will be 11 weeks. Total study duration will be 39 months. All treatment and study visits will occur at Mayo Clinic in Rochester, MN.

Conditions

  • Stiff-Person Syndrome

Interventions

DRUG

Intravenous Immunoglobulins, Human

Immunoglobulins are fractionated blood products made from pooled human plasma.

DRUG

Placebos

Normal Saline

Sponsors & Collaborators

  • Grifols Biologicals, LLC

    collaborator INDUSTRY

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Andrew McKeon, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-07
Primary Completion
2019-04-26
Completion
2019-04-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749096 on ClinicalTrials.gov