Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034242
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-04-24
Brief Title:
High-Dose Intravenous Immunoglobulin to Treat Cerebellar Degeneration
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Efficacy of High-Dose Intravenous Immunoglobulin Therapy In Patients With Cerebellar Degeneration A Double Blind Placebo Controlled Trial
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
There is increasing evidence that there is an antibody mediated autoimmune component in hereditary and sporadic cerebellar degeneration The objective of this study is to show clinical improvement or stabilization in ataxia using treatment with intravenous immunoglobulin IVIG treatment This study is a clinical randomized placebo-controlled trial of IVIG in adult patients with cerebellar ataxia Patients will be selected from the motor control clinic based on a diagnosis of sporadic or hereditary cerebellar degeneration Study drug placebo versus active will be given in an intravenous infusion over a 2-day period while the patient is hospitalized This will be repeated monthly for 2 months Efficacy measurement will include clinical ataxia rating scales motor speed testing and clinical gait evaluation These will be performed at baseline during each hospitalization and 1 month following final IVIG infusion Main outcome measure will be difference from baseline in score on the NINDS ataxia rating scale 1 month following 2 treatments of 2 mgkg IVIG total 4 mgkg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0185 | None | None | None |