Last updated on November 2019

Oral LAT8881 in Neuropathic Pain


Brief description of study

This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain.

Detailed Study Description

This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain. After a one week baseline period, subjects entered into the study will be randomised to receive Investigational Medicinal Product (IMP) (LAT8881 or placebo) twice daily for four weeks.

The first treatment period will be followed by a washout period of two weeks and then a second baseline period of one week. Subjects will not take any IMP over these three weeks.

After the second baseline period, subjects will cross over to receive the second treatment (either LAT8881 or placebo, whichever treatment was not received in the first treatment period) twice daily for four weeks.

The pharmacokinetics (PK) of LAT8881 will be investigated in 15 subjects (PK subjects) at selected Australian sites. Quantitative sensory testing (QST) for Warm Detection Threshold (WDT), Mechanical Pain Sensitivity (MPS) and Heat Pain Threshold (HPT) will be performed in at least 20 subjects (QST subjects) in each treatment period, before the first dose and on the last day of each period. No subject will have both PK and QST analyses.

Clinical Study Identifier: NCT03865953

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Emeritus Research Services

Melbourne, Australia
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