LAT8881 in Neuropathic Pain
Research type
Research Study
Full title
A Phase IIa study of the efficacy and safety of oral LAT8881 in neuropathic pain
IRAS ID
257815
Contact name
Anthony Pickering
Contact email
Sponsor organisation
Lateral Pharma Pty Ltd
Eudract number
2018-004534-15
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
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 study drug (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 drug 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 primary measure of whether or not the study drug is effective will be assessed by the change in mean pain intensity scores from baseline to the end of four weeks treatment, based on an 11 point numeric pain rating scale (NPRS).
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, 1 UK site only) 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.
Number of Subjects Planned It is planned to have 44 subjects complete the study. Assuming a 20% dropout, 55 subjects will be recruited.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0099
Date of REC Opinion
4 Jun 2019
REC opinion
Further Information Favourable Opinion