Oral LAT8881 in Neuropathic Pain

• Status: Completed
• Trial end date: 2020-05-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lateral Pharma Pty Ltd

Criteria

Inclusion Criteria:

1. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash OR

2. Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes mellitus with:

1. symmetrical, bilateral pain in the lower extremities for at least 3 months and

2. diabetes under control for at least 3 months prior to randomisation, as indicated by a glycated haemoglobin level (HbA1c) of ≤ 11% (97 mmol/mol) and on a stable dose of insulin or oral diabetic medication for 3 months prior to screening, and

3. no change in diabetic medication planned for the duration of the study

3. Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by:

1. painDETECT questionnaire (PD-Q) and

2. Clinical assessment, showing signs of neuropathic pain in either a dermatomal (PHN) or distal symmetrical distribution (DPN)

8. An average daily pain score on the numeric pain rating scale (NPRS) of at least 4 and no more than 8 in the last five diary entries before randomisation

Exclusion Criteria:

1. Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.

2. Subjects with both DPN and PHN