Oral LAT8881 in Neuropathic Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-09

Study Completion Date

2020-05-03

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is the first study with LAT8881 in subjects with neuropathic pain. As such, it has been designed to evaluate, in a well-defined patient group, the concept that LAT8881 is safe and effective in this indication.

Subjects enrolled into this study have been diagnosed with Post Herpetic Neuralgia (PHN) or Diabetic Peripheral Neuropathy (DPN), both conditions being well accepted examples of neuropathic pain. Because the pain is chronic, without a period effect, and treatment is symptomatic rather than curative, a crossover study is considered appropriate. Studies with other agents have successfully demonstrated analgesic effects in PHN and DPN with a crossover study design

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LAT8881

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

Group Type ACTIVE_COMPARATOR

LAT8881

Intervention Type DRUG

LAT8881 oral capsule

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral capsule

Interventions

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LAT8881

LAT8881 oral capsule

Intervention Type DRUG

Placebo

Placebo oral capsule

Intervention Type DRUG

Eligibility Criteria

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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