Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia
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ClinicalTrials.gov Identifier: NCT01350440 |
Recruitment Status
:
Completed
First Posted
: May 9, 2011
Last Update Posted
: July 23, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinocerebellar Ataxia | Biological: IVIG | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: IVIG
Intravenous Immune Globulin
|
Biological: IVIG
Intravenous Immune Globulin
|
- Scale for the Assessment and Rating of Ataxia [ Time Frame: participants will be followed for approximately 4 months ]
- Timed 25 foot walk [ Time Frame: participants will be followed for approximately 4 months ]
- Clinical Global impression [ Time Frame: participants will be followed for approximately 4 months ]
- Biodex Balance SD [ Time Frame: participants will be followed for approximately 4 months ]
- Gait Rite Mat [ Time Frame: participants will be followed for approximately 4 months ]
- Berg balance scale [ Time Frame: participants will be followed for approximately 4 months ]
- Complete Metabolic Panel [ Time Frame: participants will be followed for approximately 4 months ]
- Complete Blood Count [ Time Frame: participants will be followed for approximately 4 months ]

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Ages Eligible for Study: | 10 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Outpatients with SCA diagnosed by a movement disorder specialist.
- Age 10 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.
- Stable doses of all antidepressants and vitamins (including internet purchased idebenone) for 30 days prior to study entry and for the duration of the study. Throughout the study, all possible efforts should be made to maintain stable doses of all other medications.
- 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 clinically significant cardiac disease (as determined by the investigator based on EKG and echocardiogram results within the past 6 months). Specifically, an ejection fraction <40%, or a prolonged QT interval (>50% of cycle duration) will be excluded. If the investigator notes clinically significant abnormalities on the EKG or echocardiogram, the subject will be eligible IF they provide clearance from a cardiologist.
- Presence of diabetes (as determined by blood glucose labs within the past 6 months).
- 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 (AST or ALT>2x times normal) (as evidenced by labs reported within the past 6 months).
- Clinically significantly abnormal WBC, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
- IgA deficiency (evidenced by screening lab evaluations)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350440
United States, Florida | |
University of South Florida | |
Tampa, Florida, United States, 33612 |
Principal Investigator: | Theresa Zesiewicz, MD | University of South Florida |
Responsible Party: | Theresa Zesiewicz, Professor of Neurology, University of South Florida |
ClinicalTrials.gov Identifier: | NCT01350440 History of Changes |
Other Study ID Numbers: |
10 |
First Posted: | May 9, 2011 Key Record Dates |
Last Update Posted: | July 23, 2013 |
Last Verified: | July 2013 |
Additional relevant MeSH terms:
Spinocerebellar Ataxias Spinocerebellar Degenerations Ataxia Cerebellar Ataxia Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Cerebellar Diseases Brain Diseases Central Nervous System Diseases |
Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Immunoglobulins Antibodies gamma-Globulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |