Status:
COMPLETED
Safety and Pharmacokinetics Study of Oral Lithium in Patients With Chronic Spinal Cord Injury
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
China Spinal Cord Injury Network
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00431171
Start Date
September 1 2007
End Date
January 1 2010
Last Update
January 16 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MacLehose Medical Rehabilitation Centre
Pokfulam, Hong Kong SAR, China