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Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury

NCT00431171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-01-16

No results posted yet for this study

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 0.6 mmol/L to 1.2 mmol/L for six weeks in subjects with chronic spinal cord injury.

Conditions

  • Spinal Cord Injuries

Interventions

DRUG

Lithium carbonate

Sponsors & Collaborators

  • China Spinal Cord Injury Network

    collaborator NETWORK

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Yat-wa Wong, MD · The University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00431171 on ClinicalTrials.gov