Oral LAT8881 in Neuropathic Pain

NCT03865953 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: LAT-NP-0012018-004534-15
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  The 11-point numeric pain rating scale (NPRS) ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain. The efficacy of oral LAT8881 in neuropathic pain was compared with placebo, when assessed by change in mean pain intensity scores, using this 11 point numeric pain rating scale.

  Baseline to Week 4

Secondary Outcomes (14)

• Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo

  Pre-dose, 0.5,1,2,4 and 6 hours after the first and last dose of LAT8881 and placebo

• Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS

  1,2 and 3 weeks

• 30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.

  4 weeks

• 50% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.

  4 weeks

• Maximum Change in Mean NPRS

  1,2,3 or 4 weeks

Study Arms (2)

LAT8881

ACTIVE COMPARATOR

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

Drug: LAT8881

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LAT8881 DRUG

LAT8881 oral capsule

LAT8881

Placebo DRUG

Placebo oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Lateral Pharma Pty Ltd: lead

Study Sites (6)

Paratus Clinical Research Kanwal

Kanwal, New South Wales, 2259, Australia

Location

Paratus Clinical Research Blacktown

Sydney, New South Wales, 2148, Australia

Location

AusTrials

Brisbane, Queensland, 4075, Australia

Location

Emeritus Research Services

Melbourne, Victoria, 3124, Australia

Location

University of Bristol

Bristol, BS8 1TD, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G121 3UW, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mr David Kenley
• Organization: Lateral Pharma Pty Ltd

dk@lateral-pharma.com

+61 (0)400 151 490

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 2, 2019
• First Posted: March 7, 2019
• Study Start: April 9, 2019
• Primary Completion: April 19, 2020
• Study Completion: May 3, 2020
• Last Updated: June 14, 2021
• Results First Posted: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); AU (4)