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Immunomodulator
IVIG for Ataxia
Phase 1
Waitlist Available
Led By Theresa Zesiewicz, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years to 80 years
Able to ambulate with or without assistance for 30 feet
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be assesed at abseline, day 14, day28 and day 56.
Awards & highlights
Study Summary
This trial will study the effects of IVIG on SCA symptoms and motor/nervous system function in different subtypes of the disease.
Who is the study for?
This trial is for adults aged 18-80 with Spinocerebellar Ataxia types 1, 2, 3, 6, 10 or 11. Participants must be able to walk (with/without help), have stable medication doses for a month before and during the study, use reliable contraception if applicable, and not have significant blood or organ function issues.Check my eligibility
What is being tested?
The trial tests how Intravenous Immune Globulin (IVIG) affects symptoms and motor/nervous system functions in patients with various subtypes of Spinocerebellar Ataxia. It's an open-label study where all participants receive IVIG.See study design
What are the potential side effects?
Possible side effects of IVIG include headache, fever, chills, fatigue, nausea/vomiting; allergic reactions like skin rash; possible kidney dysfunction; low blood pressure; chest discomfort/pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I can walk 30 feet with or without help.
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I am using birth control and can provide a negative pregnancy test.
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My medication doses have been stable for the last 30 days and will remain so during the study.
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I have been diagnosed with peripheral neuropathy.
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I have been diagnosed with a specific type of movement disorder by a specialist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ will be assesed at abseline, day 14, day28 and day 56.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be assesed at abseline, day 14, day28 and day 56.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Scale for the Assessment and Rating Ataxia (SARA)
Secondary outcome measures
9-hole peg test
Neurologic dysfunction as assessed by STAND scores
clinician and patient global impression of improvement (CGI and PGI)
Side effects data
From 2019 Phase 1 & 2 trial • 27 Patients • NCT0399248215%
Ocular discomfort
15%
Blurring of vision
15%
Dryness
8%
Light sensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
IVIG-Eye Drop
Placebo-Eye Drop
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intravenous Immune Globulin (IVIG)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous Immune Globulin (IVIG)
2019
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
University of South FloridaLead Sponsor
408 Previous Clinical Trials
186,836 Total Patients Enrolled
5 Trials studying Spinocerebellar Ataxias
274 Patients Enrolled for Spinocerebellar Ataxias
Baxter Healthcare CorporationIndustry Sponsor
315 Previous Clinical Trials
200,058 Total Patients Enrolled
1 Trials studying Spinocerebellar Ataxias
5 Patients Enrolled for Spinocerebellar Ataxias
Theresa Zesiewicz, MDPrincipal InvestigatorUniversity of South Florida
6 Previous Clinical Trials
282 Total Patients Enrolled
3 Trials studying Spinocerebellar Ataxias
225 Patients Enrolled for Spinocerebellar Ataxias
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your recent blood tests show a significant problem with your white blood cells, hemoglobin, or platelets.You have low levels of certain vitamins or immunoglobulin A, as shown by lab tests.I am between 18 and 80 years old.I can walk 30 feet with or without help.I am using birth control and can provide a negative pregnancy test.My medication doses have been stable for the last 30 days and will remain so during the study.We will try our best to help you stay active and do physical exercises during the study.I have diabetes or a condition known to cause nerve damage.You have a serious mental illness, like dementia, that stops you from understanding and agreeing to take part in the study.I have severe kidney or liver disease.I have been diagnosed with peripheral neuropathy.I am legally unable to make my own decisions.I have been diagnosed with a specific type of movement disorder by a specialist.Your recent blood and heart tests show that everything is normal and healthy.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous Immune Globulin (IVIG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age bracket for this trial restricted to those over a certain age?
"This medical trial only accepts applicants between the ages of 18 to 80; for patients younger or older than this, there are extra trials available with a total of 51 studies in all."
Answered by AI
What are the eligibility criteria for enrollment in this experiment?
"This medical study is open to those suffering from spinocerebellar ataxias, between the ages of 18 and 80. The total cap for participants has been set at 10 individuals."
Answered by AI
Has the FDA sanctioned Intravenous Immune Globulin (IVIG) for medical use?
"Our team at Power cautiously rates the safety of IVIG a 1 as it is currently in its first phase, with limited evidence affirming efficacy and safety."
Answered by AI
Are any recruitment opportunities for this medical trial still available?
"The information hosted on clinicaltrials.gov attests that this specific trial is not recruiting participants at the current time, as it was last updated in June 2016. Fortunately, there are 46 additional studies currently enrolling patients who seek medical treatment or intervention."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
University of South Florida
What portion of applicants met pre-screening criteria?
Met criteria
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