Oral LAT8881 in Neuropathic Pain

Lateral Pharma

Status and phase: Completed; Phase 2

Conditions: Post Herpetic Neuralgia (PHN); Neuropathic Pain; Diabetic Peripheral Neuropathy (DPN)

Treatments: Drug: Placebo; Drug: LAT8881

Study type: Interventional

Funder types: Industry

Identifiers

NCT03865953

2018-004534-15 (EudraCT Number)

LAT-NP-001

Details and patient eligibility

About

This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to investigate the efficacy and safety of oral LAT8881 in neuropathic pain.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

4. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

LAT8881

Active Comparator group

Description:

1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period.

Treatment:

Drug: LAT8881

Placebo

Placebo Comparator group

Description:

1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period.

Treatment:

Drug: Placebo