NCT03865953

Oral LAT8881 in Neuropathic Pain

A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Lateral Pharma Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neuropathic Pain
• Diabetic Peripheral Neuropathy (DPN)
• Post Herpetic Neuralgia (PHN)

Interventions

Type	Name	Description
DRUG	LAT8881	LAT8881 oral capsule
DRUG	Placebo	Placebo oral capsule

Timeline

• Start date: 2019-04-09
• Primary completion: 2020-04-19
• Completion: 2020-05-03
• First posted: 2019-03-07
• Last updated: 2021-06-14
• Results posted: 2021-04-23

Locations

6 sites across 2 countries: Australia, United Kingdom

Regulatory

• FDA-regulated drug study