Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


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 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


Study is Available At:


Original ID:

18-007041


NCT ID:

NCT03749096


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

IVIg in Glycine Receptor Antibody Positive Stiff-person Syndrome (SPS) Spectrum Disorders.


Overall Status:

Withdrawn


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:

Recruitment did not meet sponsors timeline


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew McKeon, MD
Principal Investigator
Mayo Clinic

Study Dates

Start Date:December 7, 2018
Completion Date:April 26, 2019
Completion Type:Actual
Primary Completion Date:April 26, 2019
Primary Completion Type:Actual
Verification Date:June 2019
Last Changed Date:June 11, 2019
First Received Date:November 16, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in Heightened-sensitivity scale
Time Frame:Screen, Week 11
Safety Issues:False
Description: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 nocturna
Outcome Type:Primary Outcome
Measure:Change in Distribution-of-stiffness index
Time Frame:Screen, Week 11
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Drug
Name:Intravenous Immunoglobulins, Human
Description:Immunoglobulins are fractionated blood products made from pooled human plasma.
Arm Name:Intravenous immunoglobulin
Intervention Type:Drug
Name:Placebos
Description:Normal Saline
Arm Name:Placebo
Other Name:Normal Saline

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Study Arm Type:Active Comparator
Arm Name:Intravenous immunoglobulin
Description: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).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Grifols Biologicals, LLC

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.