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An Open-label Trial of Intravenous Immune Globulin (IVIG)in Treating Spinocerebellar Ataxias

Information source: University of South Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinocerebellar Ataxias

Intervention: Intravenous Immune Globulin (IVIG) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
Theresa Zesiewicz, MD, Principal Investigator, Affiliation: University of South Florida

Overall contact:
Mary Freeman, LPN, Phone: 813-974-5909


The purpose of this study is to learn how Intravenous Immune Globulin (IVIG) will affect Spinocerebellar Ataxia (SCA) symptoms and how it will affect motor and nervous system function in participants Subtypes of SCA to be examined will include SCA types 1, 2, 3, 6, 10 and 11.

Clinical Details

Official title: An Open-label Trial of Intravenous Immune Globulin (IVIG)in Treating Spinocerebellar Ataxias

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes in Scale for the Assessment and Rating Ataxia (SARA)

Secondary outcome:

clinician and patient global impression of improvement (CGI and PGI)

Neurologic dysfunction as assessed by STAND scores

9-hole peg test


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


Inclusion Criteria:

- Outpatients with SCA types 1, 2, 3, 6, 10, or 11, diagnosed by a movement disorder


- Age 18 years to 80 years.

- Able to ambulate with or without assistance for 30 feet.

- Women of child-bearing potential must use a reliable method of contraception and must

provide a negative pregnancy test at entry into the study.

- Serum creatine kinase, complete metabolic panel, complete blood count, liver function

tests, renal function tests, platelets and EKG do not reveal clinically significant abnormalities (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).

- Stable doses of all medications for 30 days prior to study entry and for the duration

of the study.

- Diagnosis of peripheral neuropathy. See exclusion criteria 3 for specific types of

peripheral neuropathy to be excluded.

- Throughout the study, all possible efforts will be made to maintain subject levels of

activity, exercise or physical therapy.

- Subject permission (informed consent).

Exclusion Criteria:

- Any unstable illness that in the investigator's opinion precludes participation in

this study.

- Use of any investigational product within the past 30 days.

- Presence of diabetes (as determined by blood glucose labs within the past 6 months),

nutritional deficiency causing neuropathy (vitamin B1, 3, 6, and 12 or vitamin E), injuries, autoimmune disorders (HIV, lupus, pediatric Guillain-Barre syndrome, neurosarcoidosis, monoclonal gammopathy), tumors, infections (leprosy), exposures to toxins (alcohol, arsenic, mercury), thyroid disease or hereditary causes (cerebral amyloid angiopathy) known to result in the presence of peripheral neuropathy.

- Dementia or other psychiatric illness that prevents the subject from giving informed

consent (MMSE less than 25).

- Legal incapacity or limited legal capacity.

- Presence of severe renal disease (estimated creatinine clearance <50 mL/min) or

hepatic disease (as evidenced by labs reported within the past 6 months).

- Clinically significantly abnormal white blood cell count, hemoglobin or platelet

count (as evidenced by labs reported within the past 6 months).

- Immunoglobulin A, Vitamin B (1, 3, 6, or 12), vitamin E or folate deficiencies

(evidenced by screening lab evaluations).

Locations and Contacts

Mary Freeman, LPN, Phone: 813-974-5909

University of South Florida, Tampa, Florida 33612, United States; Recruiting
Mary Freeman, LPN, Phone: 813-974-5909
Tanya Aranca, BS, Phone: 813-974-5909
Additional Information

Starting date: April 2015
Last updated: May 26, 2015

Page last updated: August 23, 2015

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