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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: China Spinal Cord Injury Network
• Treatments: Lithium Carbonate

Criteria

Inclusion Criteria:

• Subjects of either gender and 18 - 60 years of age (preferably 10 males and females each)

• Subjects with chronic spinal cord injury (defined as 12 months or more post spinal cord injury), as confirmed by a MRI

• Subjects with neurological status: ASIA A, B or C

• Subjects must be able to read, understand, and complete the VAS

• Subjects who have voluntarily signed* and dated* an informed consent form, approved by an IEC/IRB, prior to any study-specific procedures *If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process.

Exclusion Criteria: Subjects are excluded if they have

• a history of hypersensitivity to lithium

• significant renal, cardiovascular, hepatic and psychiatric diseases

• significant medical diseases or infection

• brain injury

• Addison's disease

• debilitation or dehydration

• recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracycline

• a history of alcohol abuse or drug abuse, or if they are

• pregnant or lactating women;

• female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study;

• subjects who are currently participating in another investigational study or have been taking any investigational drug within the last 4 weeks prior to screening of this study (Visit 1); and finally,

• any criteria, which, in the opinion of the investigator, suggest that the subject would not be compliant with the study protocol.