Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT01350440
First received: April 20, 2011
Last updated: July 19, 2013
Last verified: July 2013

April 20, 2011
July 19, 2013
August 2011
July 2013   (final data collection date for primary outcome measure)
Scale for the Assessment and Rating of Ataxia [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01350440 on ClinicalTrials.gov Archive Site
  • Timed 25 foot walk [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: No ]
  • Clinical Global impression [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: No ]
  • Biodex Balance SD [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: No ]
  • Gait Rite Mat [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: No ]
  • Berg balance scale [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: No ]
  • Complete Metabolic Panel [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: Yes ]
  • Complete Blood Count [ Time Frame: participants will be followed for approximately 4 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia

This is a preliminary study to determine the safety and efficacy of intravenous immune globulin in treating Spinocerebellar Ataxia. The investigators aim to assess changes in clinical measures of disease severity before and after treatment.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spinocerebellar Ataxia
Biological: IVIG
Intravenous Immune Globulin
Experimental: IVIG
Intravenous Immune Globulin
Intervention: Biological: IVIG
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Outpatients with SCA diagnosed by a movement disorder specialist.
  2. Age 10 years to 80 years.
  3. Able to ambulate with or without assistance for 30 feet.
  4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
  5. 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).
  6. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
  7. 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.
  8. Subject permission (informed consent).

Exclusion Criteria:

  1. Any unstable illness that in the investigator's opinion precludes participation in this study.
  2. Use of any investigational product within the past 30 days.
  3. 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.
  4. Presence of diabetes (as determined by blood glucose labs within the past 6 months).
  5. Dementia or other psychiatric illness that prevents the subject from giving informed consent (MMSE less than 25).
  6. Legal incapacity or limited legal capacity.
  7. 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).
  8. Clinically significantly abnormal WBC, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
  9. IgA deficiency (evidenced by screening lab evaluations)
Both
10 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01350440
10
Not Provided
Theresa Zesiewicz, University of South Florida
University of South Florida
Baxter Healthcare Corporation
Principal Investigator: Theresa Zesiewicz, MD University of South Florida
University of South Florida
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP