Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-28 @ 5:12 AM
Study NCT ID:
NCT00750061
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2008-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries
Sponsor:
China Spinal Cord Injury Network
Organization:
Study Overview
Official Title:
Efficacy and Safety pf Lithium Carbonate in the Treatment of Chronic Spinal Cord Injuries: a Double-Blind, Randomized, Placebo-Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-04
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 is a randomized, placebo-controlled, double-blinded trial. Forty patients will be randomized into two groups. The subjects in the Treatment Group will be administered with lithium carbonate, while the Control Group will receive placebo.
Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.
The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.
Each subject will receive oral lithium carbonate or placebo for six weeks. In the treatment group, the dose will be adjusted according to the serum lithium level while in the control group there will be a sham adjustment.
The outcomes will be assessed 6 weeks and 6 months after the onset of the medication. The outcomes will be compared with baseline pre-treatment data to obtain "neurological change scores." The efficacy and safety will be analyzed comparing the results of the treatment group with those of the control group.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: