Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    LAT8881
Previous Study | Return to List | Next Study

Oral LAT8881 in Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03865953
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Lateral Pharma Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Diabetic Nephropathies Post Herpetic Neuralgia Drug: LAT8881 Drug: Placebo Phase 2

Detailed 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. Quantitative sensory testing (QST) for Warm Detection Threshold (WDT), Mechanical Pain Sensitivity (MPS) and Heat Pain Threshold (HPT) will be performed in at least 20 subjects (QST subjects) in each treatment period, before the first dose and on the last day of each period. No subject will have both PK and QST analyses.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: LAT8881
1 x 30 mg capsule of LAT8881 taken by mouth, twice daily (morning and evening) during the four-week treatment period.
Drug: LAT8881
LAT8881 oral capsule

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




Primary Outcome Measures :
  1. Absolute change in mean pain score, using an 11 point numeric pain rating scale (NPRS) [ Time Frame: 4 weeks ]

    The 11-point numeric scale ranges from '0' representing one pain extreme e.g. "no pain" to '10' representing the other pain extreme e.g. "worst pain imaginable"

    We will be evaluating the efficacy of oral LAT8881 in neuropathic pain compared with placebo when assessed by change in mean pain intensity scores, using this 11 point numeric pain rating scale.



Secondary Outcome Measures :
  1. Change in NPRS score after the first dose of IMP in each treatment period [ Time Frame: Pre-dose, 0.5,1,2,4 and 6 hours ]
    To investigate the effect of oral LAT8881 in neuropathic pain compared with placebo as measured by the NPRS. This is only being investigated in pharmacokinetic subjects.

  2. Change in NPRS score after a single dose of IMP in each treatment period [ Time Frame: Pre-dose, 0.5,1,2,4 and 6 hours ]
    To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo as measured by the NPRS.

  3. Change in mean pain scores, using NPRS [ Time Frame: 1,2 and 3 weeks ]
    To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo as measured by the NPRS.

  4. 30% responder rate in oral LAT8881 compared with placebo [ Time Frame: 4 weeks ]
    To determine the proportion of subjects with at least a 30% reduction in mean NPRS

  5. 50% responder rate in oral LAT8881 compared with placebo [ Time Frame: 4 weeks ]
    To determine the proportion of subjects with at least a 50% reduction in mean NPRS

  6. Maximum change in mean NPRS [ Time Frame: 1,2,3 or 4 weeks ]
    To determine the maximum effects of oral LAT8881 in neuropathic pain, compared with placebo.

  7. Change in functioning as assessed by the Brief Pain Inventory Interference Scale (BPI) [ Time Frame: 4 weeks ]

    The Brief Pain Inventory Interference Scale (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. Patients are asked to rate the level of interference experienced for each of these items, with a "0" meaning "no interference, and a "10", at the top end of the scale, meaning "complete interference".

    The BPI will be evaluating the effects of oral LAT8881, compared with placebo, on functioning in subjects with neuropathic pain when measured by the 7-item short form BPI Interference Scale.


  8. Change in pain characteristics and intensity, as assessed by the Short Form McGill Pain Questionnaire- (SF-MPQ-2) [ Time Frame: 4 weeks ]
    To evaluate the effect of oral LAT8881, compared with placebo, on pain symptoms in subjects with neuropathic pain, when measured by the SF-MPQ-2.

  9. Change in neuropathic pain symptoms, as assessed by Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: 4 weeks ]
    To evaluate the effect of oral LAT8881, compared with placebo, on symptoms in subjects with neuropathic pain, when measured by the NPSI.

  10. Change in emotional functioning, as assessed by the Beck Depression Inventory-II [ Time Frame: 4 weeks ]
    To evaluate the effect of oral LAT8881, compared with placebo, on emotional functioning when measured by the Beck Depression Inventory-II (BDI-II).

  11. Patient Global Impression of Change Score [ Time Frame: 4 weeks ]

    The Patient Global Impression of Change is a self-rated measure, where patients are asked to describe the change, if any, since beginning treatment, in: activity limitations, symptoms, emotions and overall quality of life related to their neuropathic pain. Patients are asked to rate the change, if any, for these items on a 7-point scale, where "0" equals "no change", through to "7", meaning "a great deal better".

    The PGIC is being used to evaluate the effect of oral LAT8881, compared with placebo, on overall health and quality of life in subjects with neuropathic pain,.


  12. Rescue medication use [ Time Frame: Weekly over four-week treatment ]
    To determine the change from baseline in paracetamol rescue medication use during oral LAT8881 administration, compared with placebo.

  13. Pharmacokinetics of twice daily oral LAT8881 [ Time Frame: up to 4 weeks of treatment ]

    Pharmacokinetic parameters in PK subjects :

    Maximum Plasma Concentration (Cmax) Time at which Maximum Plasma Concentration is observed (Tmax)


  14. Pharmacokinetics of twice daily oral LAT8881 [ Time Frame: up to 4 weeks of treatment ]

    Pharmacokinetic parameters in PK subjects :

    Area Under the Curve (AUC)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865953


Contacts
Layout table for location contacts
Contact: Nicky Wallis +61 438 020 177 nwallis@lateral-pharma.com
Contact: David Kenley +61 400 151 490 dk@lateral-pharma.com

Locations
Layout table for location information
Australia, New South Wales
Australian Medical Research Recruiting
Hurstville, New South Wales, Australia, 2220
Australia, Queensland
AusTrials Recruiting
Brisbane, Queensland, Australia, 4075
Australia, Victoria
Emeritus Research Services Recruiting
Melbourne, Victoria, Australia, 3124
Sponsors and Collaborators
Lateral Pharma Pty Ltd
Investigators
Layout table for investigator information
Principal Investigator: Anthony Pickering, PhD, MB ChB University of Bristol

Layout table for additonal information
Responsible Party: Lateral Pharma Pty Ltd
ClinicalTrials.gov Identifier: NCT03865953     History of Changes
Other Study ID Numbers: LAT-NP-001
2018-004534-15 ( EudraCT Number )
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is an Early Proof of Concept study

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Neuralgia, Postherpetic
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases