CompletedPhase 2

Oral LAT8881 in Neuropathic Pain

Australia, United Kingdom53 participantsStarted 2019-04-09

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash OR
✓. Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes mellitus with:
✓. symmetrical, bilateral pain in the lower extremities for at least 3 months and
✓. 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
✓. no change in diabetic medication planned for the duration of the study
✓. Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by:
✓. painDETECT questionnaire (PD-Q) and
✓. Clinical assessment, showing signs of neuropathic pain in either a dermatomal (PHN) or distal symmetrical distribution (DPN)

Exclusion criteria

✕. Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.
✕. Subjects with both DPN and PHN

What they're measuring

Absolute Change in Mean Pain Score, Using an 11 Point Numeric Pain Rating Scale (NPRS)

Timeframe: Baseline to Week 4

Trial details

NCT IDNCT03865953

SponsorLateral Pharma Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-04-19

Results submitted2021-03-03

View on ClinicalTrials.gov More Neuropathic Pain trials