Study of IVIg vs. Placebo to Treat Subjects with Stiff-Person Syndrome (SPS) Spectrum Disorders

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-007041
    NCT ID: NCT03749096
    Sponsor Protocol Number: 18-007041

About this study

The purpose of this study is to assess in a blinded, randomized controlled fashion, whether 9 weeks of immunoglobulin therapy (IVIG) can reduce stiffness and spasms in subjects with Stiff-Person Syndrome (SPS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older.
  • Must have symptoms of SPS for less than 3 years.
  • If taking corticosteroids, the patients must be on a stabile dose for 30 days prior to enrolment.
  • Patients will have a diagnosis of SPS spectrum disorder based on both of:
    • Clinical: rigidity with muscle co-contraction affecting 2 or more body parts (lower trunk, upper trunk, one or both legs, one or both arms, craniocervical region, and abdomen) and episodic spasms precipitated by unexpected noises, tactile stimuli, or emotional upset; the absence of any other neurologic disease that could explain the stiffness; and
    • Serological: GlyRα1 antibody positive in serum, CSF (or both). The presence of coexisting antibodies is not exclusionary, as these are commonly encountered.

Exclusion Criteria:

  • Patients on immune suppressants initiated/dose increased in the prior 6 months.
  • History of thrombotic episodes within the 2 years prior to enrolment.
  • Known allergic or other severe reactions to blood products including intolerability to previous IVIG.
  • Previous adequate trial of IVIG as determined by the Principal Investigator.
  • IgA deficiency.
  • Reproductive status:
    • Women who are pregnant;
    • Women who are breastfeeding;
    • Women and men of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the investigator (women of non-childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for > 12 months prior to screen visit).
  • Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
  • Evidence of serious uncontrolled concomitant diseases that may preclude patient participation (physician determined) as described.
  • Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
  • Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
  • Evidence of chronic active hepatitis B or C.
  • Active ischemic heart disease in the past year prior to baseline.
  • Patients should not have severe renal or hepatic disease (determined by treating physician).
  • Severe hypertension (diastolic pressure >120 mmHg or systolic >170 mmHg).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew McKeon, M.B., B.Ch., M.D.

Contact us for the latest status

Contact information:

Jessica Sagen M.A.

Sagen.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20443511

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