Phase 2
N=53
Oral LAT8881 in Neuropathic Pain
Neuropathic Pain · Diabetic Peripheral Neuropathy (DPN) · Post Herpetic Neuralgia (PHN)
Bottom Line
View on ClinicalTrials.gov: NCT03865953 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Absolute Change in Mean Pain Score, Using an 11 Point Numeric Pain Rating Scale (NPRS) — -0.87; -0.74 score on a scale — p=0.67
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LAT8881 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lateral Pharma Pty Ltd
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Mean Pain Score, Using an 11 Point Numeric Pain Rating Scale (NPRS) |
-0.87; -0.74 | 0.67 |
| SECONDARY Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo |
4.5; 4.8; -0.1; -0.2; -0.4; -0.6 | — |
| SECONDARY Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS |
6.18; 6.18; -0.50; -0.55; -0.73; -0.91 | — |
| SECONDARY 30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale. |
20; 19 | — |
| SECONDARY 50% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale. |
6; 9 | — |
| SECONDARY Maximum Change in Mean NPRS |
-1.53; -1.55 | — |
| SECONDARY Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI) |
4.71; 4.91; -0.57; -1.12 | — |
| SECONDARY Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2) |
3.88; 3.86; -0.66; -0.63 | — |
| SECONDARY Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI) |
40.7; 41.1; -6.0; -7.4 | — |
| SECONDARY Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II |
11.3; 12.1; -1.1; -1.2 | — |
| SECONDARY Patient Global Impression of Change Score |
4.5; 4.8 | — |
| SECONDARY Rescue Medication Use |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881 |
NA; NA; NA; NA | — |
| SECONDARY Time to Maximum Plasma Concentration of LAT8881 (Tmax) |
NA; NA; NA; NA | — |
| SECONDARY Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) |
NA; NA; NA; NA | — |
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.
Eligibility Criteria
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)
- 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
- Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.
- Subjects with both DPN and PHN
Data sourced from ClinicalTrials.gov (NCT03865953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.