A DOUBLE- BLIND,RANDOMIZED,PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF INTRAVENOUS IMMUNOGLOBULIN THERAPY IN AUTOIMMUNE AUTONOMIC GANGLIONOPATHY.

Study ID
STU 032012-080

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital—St. Paul

Contact
Steve Hopkins
214-648-9275
steve.hopkins@utsouthwestern.edu

Principal Investigator
Steven Vernino

Summary

Once each participant has provided informed consent and satisfied the inclusion and exclusion criteria, the participant will be randomized to either the IVIG or placebo study treatment groups. Participants will have the option of staying at their own home, the CTSA or a local hotel at night for visits several days in a row. There will be 4 study treatment infusions (weeks 0, 3, 6 and amp; 9). Each infusion may take several days to complete and will be done as an outpatient procedure. One group (the placebo group) will receive placebo in the first half of the study, and IVIG the second half of the study. The other group will receive IVIG in both the first half and second half of the study. Thus all participants will receive IVIG the second half of the study. The primary endpoint will be achieved at the conclusion of the first half of the study, i.e. the double blind placebo controlled section.

Participant Eligibility

1. Participants aged 18 to 85.
2. Participants have neurogenic orthostatic hypotension (fall in systolic blood pressure > 30 mmHg).
3. Symptoms of orthostatic intolerance.
4. Antibodies to the neuronal AChR of the autonomic ganglia of >0.2nmol/l. Results must be within 6 months of the screening visit and there may not have been any immunomodulatory interventions since the time of the antibody measurement or the sample will need to be reconfirmed at screening.
5. Participants must be willing to withdraw from medications that affect vasoactive and autonomic function for 5 half-lives during testing (with the exception of stable doses of fludrocortisone up to 0.2 mg/day) and adhere to a regular diet.