High-Dose Intravenous Immunoglobulin to Treat Cerebellar Degeneration
Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
Participant gender:
Summary
This study will examine whether high-dose intravenous immunoglobulin (IVIG) is safe and
effective for treating cerebellar ataxia-degeneration of the cerebellum, the part of the
brain responsible for coordinating muscle movements and balance. The disease causes a slowly
progressive impairment of speech and balance, with patients often developing slurred speech,
tremor, clumsiness of the hands, and walking difficulties (ataxia). IVIG is derived from
donated blood that has been purified, cleaned and processed into a form that can be infused.
IVIG is an immune suppressant that is routinely used to treat other neurological conditions.
Patients 18 years of age and older with hereditary (genetic) or sporadic (unknown cause)
cerebellar degeneration may be eligible for this 5-month study. They must have evidence of an
immune component to their condition, such as gluten sensitivity or antiganglioside
antibodies. Candidates will be screened with a neurological examination, a review of medical
records and possibly blood tests.
Participants will be randomly assigned to receive infusions of either IVIG or placebo (an
inactive substance) through an arm vein once a month for two months. The infusions will be
given in the hospital in doses divided over 2 days, each lasting 6 to 10 hours. Before the
infusions, patients will undergo ataxia assessments through tests of coordination and balance
that may involve finger tapping, walking in a straight line, talking, and eye movements. When
the treatment is finished, patients will be followed in the clinic once a month for 3 months
for blood tests repeat ataxia assessments to evaluate the effects of treatment.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)