A Phase 3 interventional study of Intravenous Immunoglobulins, Human and Placebos in Stiff-Person Syndrome, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-13.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
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.
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 receive any treatment. In this study, investigators want to compare the effects, good and/or bad, of IVIG with placebo on participants with SPS to find out which is better. This is a "randomized, double-blind" study. Which treatment participants will receive is randomly determined. Participants have an equal chance of receiving IVIG or the placebo.
SPS spectrum cohort will include any from the SPS spectrum patient (stiff-limbs, stiff-trunk, stiff-limbs and trunk, and PERM). Study visits will be considered part of clinical care and will occur at: enrollment (will coincide with screening visit), and 11 weeks. IVIg/placebo (saline) treatments will be administered on 2 consecutive days in week 1, week 5, week 9 in all patients.
20 studies on the registry are indexed under Stiff-Person Syndrome; 8 are open to participants now.
Browse Stiff-Person Syndrome studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria
Reproductive status:
IVIg dose will be 2g/kg ideal body weight every 4 weeks (in 2 divided doses on consecutive days) for 12 weeks (3 cycles total).
Drug: Intravenous Immunoglobulins, Human
Drug: Placebos
Immunoglobulins are fractionated blood products made from pooled human plasma.
Normal Saline
Also known as: Normal Saline
Change in Distribution-of-stiffness index
Scores on this index range from 0 to 6 and reflect the extent of stiffness. with One point being given for stiffness in each of the following areas: lower trunk, upper trunk, legs, arms, face, and abdomen. Lower scores indicate less stiffness.
Time frame: Screen, Week 11
Change in Heightened-sensitivity scale
Scores range from 1 to 7 based on response; one point being given for each source of or type of spasm, as follows: unexpected noises, visual stimuli, somatosensory stimuli, voluntary activities, emotional upset or stress, no specific stimuli, and nocturnal spasms. Lower scores indicate less frequent spasms.
Time frame: Screen, Week 11
This study is withdrawn, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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