A three-month, open-label, single-arm trial evaluating the safety and pharmacokinetics of oral lithium in patients with chronic spinal cord injury.
OBJECTIVE
Lithium has recently been found to enhance neuronal regeneration and differentiation. This arouses its potential use to treat spinal cord injury patients. The safety and pharmacokinetics of lithium are not verified for this group of patients as their internal organ functions may change. This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of lithium in spinal cord injury patients.


METHODS
A total of 20 chronic spinal cord injury subjects were recruited. Oral lithium carbonate was given in divided dose to maintain the serum lithium level 0.6-1.2 mmol l(-1) for 6 weeks. Safety parameters, adverse events and pharmacokinetic data were carefully collected and monitored.


RESULTS
No severe adverse event was documented. All blood parameters remained stable. Nausea and vomiting were the most common complaints but tolerance was improved in 2 weeks for most subjects. A wide range of oral doses was required to maintain serum lithium level at the targeted range. However, the dose for individual subject was relatively constant.


CONCLUSIONS
This phase 1 clinical trial is the first report indicating the safety of lithium in chronic spinal cord injury patients. It is well tolerated after the first 2 weeks. 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.
Wong
Y W
YW
Department of Orthopaedics and Traumatology, The University of Hong Kong, Hong Kong, China. yatwa@hku.hk
Tam
S
S
So
K F
KF
Chen
J Y H
JY
Cheng
W S
WS
Luk
K D K
KD
Tang
S W
SW
Young
W
W
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D002908:Chronic Disease; D005260:Female; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D013116:Spinal Cord / Q000187:drug effects* / Q000473:pathology; D013119:Spinal Cord Injuries / Q000188:drug therapy* / Q000378:metabolism; D055815:Young Adult
D018696:Neuroprotective Agents; D016651:Lithium Carbonate