Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oral LAT8881 in Neuropathic Pain

NCTNCT03865953 (opens ClinicalTrials.gov in a new tab)Other idLAT-NP-001Other id2018-004534-15Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
53 participants (actual)
Sponsor
Lateral Pharma Pty Ltd · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

Australia, United Kingdom

Start
9 Apr 2019
Primary completion
19 Apr 2020
Completion
3 May 2020
First posted
7 Mar 2019
Last update posted
14 Jun 2021
Conditions
Neuropathic Pain · Diabetic Peripheral Neuropathy (DPN) · Post Herpetic Neuralgia (PHN)

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 2

    Oral LAT8881 in Neuropathic Pain

    NCT03865953

    9 Apr 2019 to 3 May 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • LAT8881Drug
  • PlaceboDrug

Arms2

  • Active comparator

    LAT8881

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline to Week 4

    Registry description

    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.

Secondary outcomes(14)

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

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

    Registry description

    To investigate the effect of oral LAT8881 in neuropathic pain compared with placebo, as measured by the numeric pain rating score (NPRS). The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain. This outcome was investigated only in the pharmacokinetic subset of per protocol subjects.

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

    Time frame · 1,2 and 3 weeks

    Registry description

    To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo, as measured by the numeric pain rating scale (NPRS). The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain.

  3. 30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.

    Time frame · 4 weeks

    Registry description

    To determine the proportion of subjects with at least a 30% reduction in mean NPRS after 4 weeks treatment. The 11-point numeric pain rating scale (NPRS) ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A decrease in pain score represents an improvement in pain.

  4. 50% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.

    Time frame · 4 weeks

    Registry description

    To determine the proportion of subjects with at least a 50% reduction in mean the numeric pain rating scale (NPRS) after 4 weeks treatment. The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A decrease in pain score represents an improvement in pain.

  5. Maximum Change in Mean NPRS

    Time frame · 1,2,3 or 4 weeks

    Registry description

    To determine the maximum effects of oral LAT8881 in neuropathic pain, compared with placebo, as measured by the numeric pain rating scale (NPRS). The 11-point numeric pain rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable"). A larger negative number represents a greater reduction in pain..

  6. Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI)

    Time frame · 4 weeks

    Registry description

    To evaluate the effects of oral LAT8881, compared with placebo, on functioning when measured by the Brief Pain Inventory Interference Scale (BPI). The BPI assesses the severity of pain and its impact on functioning. Patients are asked to assess the level of interference experienced across seven items; general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life, with a "0" meaning "no interference, and a "10", at the top end of the scale, meaning "complete interference". The result is the mean of the score of the seven items. A reduction in mean score indicates a decrease in interference.

  7. Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2)

    Time frame · 4 weeks

    Registry description

    To evaluate the effect of oral LAT8881, compared with placebo, on pain symptoms in subjects with neuropathic pain, when measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2). The SF-MPQ-2 contains 22 descriptors of pain and related symptoms, each scored from "0" (none) to "10" (worst possible). The scores for each descriptor at each visit are averaged to give a mean score from 0 to 10. A larger negative number represents a greater reduction in pain.

  8. Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI)

    Time frame · 4 weeks

    Registry description

    The Neuropathic Pain Symptom Inventory (NPSI) contains ten items related to different pain descriptors (e.g. burning, squeezing, electric-shock, stabbing, tingling), allowing the assessment of the different dimensions of neuropathic pain, and two items related to the frequency and duration of pain. Each pain descriptor is rated on an 11-point numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Total pain intensity score is calculated by the sum of the 10 descriptors and can range from 0 to 100. A higher score indicates a higher pain intensity. A larger negative number represents a greater reduction in pain.

  9. Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II

    Time frame · 4 weeks

    Registry description

    To evaluate the effect of oral LAT8881, compared with placebo, on emotional functioning when measured by the Beck Depression Inventory-II (BDI-II). The BDI-II consists of 21 items; each item is a list of four statements arranged in order of increasing severity about a particular symptom of depression. Each statement is scored from 0 to 3. Each of the 21 items is summed to give a single score for the BDI-II. Scores can range from 0 (no depression) to 63 (severe depression). An increase from baseline to the end of treatment indicates a deterioration.

  10. Patient Global Impression of Change Score

    Time frame · 4 weeks

    Registry description

    The Patient Global Impression of Change (PGIC) is a a single-item rating by subjects of their improvement with treatment during a clinical trial. It asks the subject to rate their improvement with therapy on a 7-point scale, ranging from substantially worse ("0") to substantially improved ("7"), with no change ("4") as the mid-point. A score above 4 indicates an improvement.

  11. Rescue Medication Use

    Time frame · Weekly over four-week treatment

    Registry description

    To determine the change from baseline in paracetamol rescue medication use during oral LAT8881 administration, compared with placebo.

  12. Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881

    Time frame · Day 1 and Day 28

    Registry description

    Cmax is calculated after the first dose of IMP on Day 1 and after 4 weeks treatment on the morning of Day 28

  13. Time to Maximum Plasma Concentration of LAT8881 (Tmax)

    Time frame · Day 1 and day 28

    Registry description

    Tmax after the first dose of investigational medicinal product (IMP) and after 4 weeks treatment with IMP

  14. Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf)

    Time frame · Day 1 and Day 28

    Registry description

    AUC0-inf after the first dose of IMP and after 4 weeks of treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline to Week 4

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

GroupValue (score on a scale)Spread
LAT8881-0.871.53
Placebo-0.742.09
Secondary and other outcome results(7)
Secondary outcomeMean· Pre-dose, 0.5,1,2,4 and 6 hours after the first and last dose of LAT8881 and placebo

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

GroupValue (score on a scale)Spread
LAT88814.52.2
Placebo4.81.9
Secondary outcomeMean· 1,2 and 3 weeks

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

GroupValue (units on a scale)Spread
LAT88816.181.53
Placebo6.181.45
Secondary outcomeCount of participants· 4 weeks

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

GroupValue (Participants)
LAT888120
Placebo19
Secondary outcomeCount of participants· 4 weeks

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

GroupValue (Participants)
LAT88816
Placebo9
Secondary outcomeMean· 1,2,3 or 4 weeks

Maximum Change in Mean NPRS

GroupValue (score on a scale)Spread
LAT8881-1.531.37
Placebo-1.551.41
Secondary outcomeMean· 4 weeks

Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI)

GroupValue (score on a scale)Spread
LAT88814.712.45
Placebo4.912.32
Secondary outcomeMean· 4 weeks

Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2)

GroupValue (score on a scale)Spread
LAT88813.881.81
Placebo3.861.73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LAT88811 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period. LAT8881: LAT8881 oral capsule0 / 510 / 515 / 51
Placebo1 x 30 mg capsule of placebo, taken by mouth, twice daily (morning and evening) during the four-week treatment period. Placebo: Placebo oral capsule0 / 510 / 516 / 51

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 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

PepBank is a research reference. Talk to a doctor before you use any peptide.