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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
Must not have
Presence of severe renal disease (estimated creatinine clearance <50 mL/min) or hepatic disease (as evidenced by labs reported within the past 6 months)
Legal incapacity or limited legal capacity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be assesed at abseline, day 14, day28 and day 56.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a treatment called IVIG, which uses healthy antibodies from donated blood. It aims to help people with certain types of Spinocerebellar Ataxia (SCA) by boosting their immune system. The goal is to see if this can improve their movement and nervous system functions. IVIg has been used for nearly three decades as an efficient treatment for various neurological diseases, including Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe kidney or liver disease.
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I am legally unable to make my own decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be assesed at abseline, day 14, day28 and day 56.
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be assesed at abseline, day 14, day28 and day 56. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in Scale for the Assessment and Rating Ataxia (SARA)
Secondary study objectives
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 • NCT03992482
15%
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
427 Previous Clinical Trials
192,621 Total Patients Enrolled
5 Trials studying Spinocerebellar Ataxias
274 Patients Enrolled for Spinocerebellar Ataxias
Baxter Healthcare CorporationIndustry Sponsor
323 Previous Clinical Trials
202,672 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

Intravenous Immune Globulin (IVIG) (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT02287064 — Phase 1
Spinocerebellar Ataxias Research Study Groups: Intravenous Immune Globulin (IVIG)
Spinocerebellar Ataxias Clinical Trial 2023: Intravenous Immune Globulin (IVIG) Highlights & Side Effects. Trial Name: NCT02287064 — Phase 1
Intravenous Immune Globulin (IVIG) (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02287064 — Phase 1
~1 spots leftby Dec 2025
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