Status:
WITHDRAWN
Randomized Placebo Controlled Trial of IVIg in Glycine Receptor Antibody Positive Stiff-person Syndrome
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Grifols Biologicals, LLC
Conditions:
Stiff-Person Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 p...
Detailed Description
The purpose of this study is to determine whether intravenous immunoglobulin (IVIG) treatment reduces stiffness and spasms in patients with SPS spectrum disorders compared to patients who do not recei...
Eligibility Criteria
Inclusion
- 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 and serological status
- Exclusion Criteria
- Patients on immune suppressants initiated/dose increased in the prior 6 months
- History of thrombotic episodes within the 2 years prior to enrollment
- 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, 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.
- Any surgical procedure within 4 weeks prior to baseline.
- Evidence of serious uncontrolled concomitant diseases that may preclude patient participation; 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 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
- Severe hypertension
Exclusion
Key Trial Info
Start Date :
December 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03749096
Start Date
December 7 2018
End Date
April 26 2019
Last Update
June 13 2019
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905