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Efficacy and Mechanism of Action of SCIg in Patients With Stiff Person Syndrome (SPS)

NCT03829826 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2019-05-14

No results posted yet for this study

Summary

This is a pilot, proof-of concept investigator-initiated trial planned for 22 patients with the diagnosis of Stiff Person Syndrome (SPS). The study will compare efficacy of treatment using subcutaneous immunoglobulin therapy (SCIg) compared to intravenous immunoglobulin (IVIg) therapy. The majority of IVIg naïve subjects (those not already receiving IVIg) are typically managed with non-immunotherapy mostly Gamma Aminobutyric Acid (GABA) -enhancing drugs such as Baclofen or Diazepam.

Conditions

  • Stiff-Person Syndrome

Interventions

BIOLOGICAL

HyQvia

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2020-02-29
Completion
2020-05-31
FDA Drug
Yes

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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 NCT03829826 on ClinicalTrials.gov