Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431171
Status:
COMPLETED
Last Update Posted:
2012-01-16
First Post:
2007-02-01
Brief Title:
Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
A Three Month Open-label Single-arm Trial Evaluating the Safety and Pharmacokinetics of Oral Lithium in Patients Diagnosed With Chronic Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2012-01
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:
The current study is a phase I open-label clinical trial to examine plasma levels after oral lithium treatments in 20 subjects with chronic spinal cord injury The subjects will receive standard doses of oral lithium used in treatment of manic depression The goal of the trial is to show feasibility and safety of maintaining plasma levels of 06 mmolL to 12 mmolL for six weeks in subjects with chronic spinal cord injury
Detailed Description:
Patients with spinal cord injury SCI usually have permanent and often devastating neurological deficits and disability There has been successful research in a number of fields that may someday help people with spinal cord injuries
The planned treatment trials will focus on the effects of oral lithium on neurological function in people with chronic spinal cord injury and those that have received umbilical cord blood mononuclear cell transplants to the spinal cord The interest in these two treatments derives from recent reports indicating that umbilical cord blood stem cells may be beneficial for spinal cord injury and that lithium may promote regeneration and recovery of function after spinal cord injury Both lithium and umbilical cord blood are widely available therapies that have long been used to treat diseases in humans
The current study is a phase I open-label clinical trial to examine plasma levels after oral lithium treatments in 20 subjects with chronic spinal cord injury The subjects will receive standard doses of oral lithium used in treatment of manic depression The goal of the trial is to show feasibility and safety of maintaining plasma levels of 06 mmolL to 12 mmolL for six weeks in subjects with chronic spinal cord injury
Lithium attracted much attention as a potential neuroregenerative therapy based on experiments in animal models of SCI in 2004 However toxic levels of lithium 15 mmolL are close to the effective levels 06 - 12 mmolL At toxic levels patients may become confused and lethargic have diarrhea upset stomach and develop tremors ataxia dysarthria and nystagmus Lithium toxicity may be compounded by sodium depletion or diuretics thiazides that inhibit kidney sodium upgrade and ACE inhibitors Plasma levels also depend on fluid inputoutput Therefore care will be taken to titrate the dose and to test plasma levels of the drug at the beginning at day 2 7 and week 6 during the treatment period
Acute toxicity usually produces relatively mild symptoms Chronic lithium toxicity may lead to more severe neurotoxic symptoms However these symptoms usually develop after 3-5 years of treatment
Data obtained from this study will be used to develop future chronic spinal cord injury clinical studies 1 randomized controlled trials with lithium versus placebo and 2 randomized controlled trials comparing effects of lithium and placebo on subjects who have received umbilical cord blood mononuclear cell transplants to the spinal cord
The planned treatment trials will focus on the effects of oral lithium on neurological function in people with chronic spinal cord injury and those that have received umbilical cord blood mononuclear cell transplants to the spinal cord The interest in these two treatments derives from recent reports indicating that umbilical cord blood stem cells may be beneficial for spinal cord injury and that lithium may promote regeneration and recovery of function after spinal cord injury Both lithium and umbilical cord blood are widely available therapies that have long been used to treat diseases in humans
The current study is a phase I open-label clinical trial to examine plasma levels after oral lithium treatments in 20 subjects with chronic spinal cord injury The subjects will receive standard doses of oral lithium used in treatment of manic depression The goal of the trial is to show feasibility and safety of maintaining plasma levels of 06 mmolL to 12 mmolL for six weeks in subjects with chronic spinal cord injury
Lithium attracted much attention as a potential neuroregenerative therapy based on experiments in animal models of SCI in 2004 However toxic levels of lithium 15 mmolL are close to the effective levels 06 - 12 mmolL At toxic levels patients may become confused and lethargic have diarrhea upset stomach and develop tremors ataxia dysarthria and nystagmus Lithium toxicity may be compounded by sodium depletion or diuretics thiazides that inhibit kidney sodium upgrade and ACE inhibitors Plasma levels also depend on fluid inputoutput Therefore care will be taken to titrate the dose and to test plasma levels of the drug at the beginning at day 2 7 and week 6 during the treatment period
Acute toxicity usually produces relatively mild symptoms Chronic lithium toxicity may lead to more severe neurotoxic symptoms However these symptoms usually develop after 3-5 years of treatment
Data obtained from this study will be used to develop future chronic spinal cord injury clinical studies 1 randomized controlled trials with lithium versus placebo and 2 randomized controlled trials comparing effects of lithium and placebo on subjects who have received umbilical cord blood mononuclear cell transplants to the spinal cord
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