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CN101: Phase I Lithium Trial |
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This Phase 1 clinical trial in Hong Kong was to assess the
safety and pharmacokinetics of 6-week course of lithium carbonate tablet in 20
patients with chronic spinal cord injury. The dose was adjusted to reach serum lithium level of 0.6-1.0mµ
. The adverse events neurological scores and pain scores were assessed and recorded. (The study completed in 2008.)
Study Sites: the University of Hong Kong / MacLehose
Medical Rehabilitation Centre.
Principal Investigator: Dr. Yat-Wa WONG
No. of Subjects enrolled: 20
Sponsorship: the Unversity of Hong Kong Spinal Cord Injury Fund (HKUSCIFund)
"This phase 1 clinical trial is the first report indicating the safety of lithium in chronic spinal cord injury patients. The drug is safe and well tolerated. Individual titration of lithium is essential to maintain an optimal serum lithium level but once the desirable level is achieved, the oral dose remains relatively unchanged for maintenance." (quoted from the Publicaiton )
For more information, please refer to:
1. Clinicaltrials.gov: NCT00431171
2. Publication: A
three-month, open-label, single-arm trial evaluating the safety and
pharmacokinetics of oral lithium in patients with chronic spinal cord
injury Spinal Cord 49, 94-98 (January 2011) | doi:10.1038/sc.2010.69
What should I do if I would like to participate in the trials of ChinaSCINet?
To learn as much as possible about the clinical trial and then
contact the investigator directly. You may also leave your basic
information and contact here ( Submit a Form). The investigators may retrieve the data
and contact you if they think you might be suitable candidate for the
trial.
To read more:
About Clinical Research
About Lithium and Cord Blood Cells
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