Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

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CW ID: 203897
Date Last Changed: March 8, 2016

Clinical Trial Snapshot

Phase
1
Gender
Both Male and Female
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
University of South Florida/Baxter Healthcare Corp
Facility Type
N/A

Eligibility

Inclusion Criteria:

  • Outpatients with SCA types 1, 2, 3, 6, 10, or 11, diagnosed by a movement disorder specialist.
  • 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).

Contact

Jessica Shaw
University of South Florida - Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612
Phone: (813)974-1414

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