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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03865953




Registration number
NCT03865953
Ethics application status
Date submitted
2/03/2019
Date registered
7/03/2019
Date last updated
8/07/2019

Titles & IDs
Public title
Oral LAT8881 in Neuropathic Pain
Scientific title
A Phase IIa Study of the Efficacy and Safety of Oral LAT8881 in Neuropathic Pain
Secondary ID [1] 0 0
2018-004534-15
Secondary ID [2] 0 0
LAT-NP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic Pain 0 0
Diabetic Nephropathies 0 0
Post Herpetic Neuralgia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Diabetes
Renal and Urogenital 0 0 0 0
Kidney disease
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LAT8881
Treatment: Drugs - Placebo

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.


Treatment: Drugs: LAT8881
LAT8881 oral capsule

Treatment: Drugs: Placebo
Placebo oral capsule

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in mean pain score, using an 11 point numeric pain rating scale (NPRS) - 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.
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Change in NPRS score after the first dose of IMP in each treatment period - 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.
Timepoint [1] 0 0
Pre-dose, 0.5,1,2,4 and 6 hours
Secondary outcome [2] 0 0
Change in NPRS score after a single dose of IMP in each treatment period - To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo as measured by the NPRS.
Timepoint [2] 0 0
Pre-dose, 0.5,1,2,4 and 6 hours
Secondary outcome [3] 0 0
Change in mean pain scores, using NPRS - To investigate the effect of oral LAT8881 on mean pain scores in neuropathic pain compared with placebo as measured by the NPRS.
Timepoint [3] 0 0
1,2 and 3 weeks
Secondary outcome [4] 0 0
30% responder rate in oral LAT8881 compared with placebo - To determine the proportion of subjects with at least a 30% reduction in mean NPRS
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
50% responder rate in oral LAT8881 compared with placebo - To determine the proportion of subjects with at least a 50% reduction in mean NPRS
Timepoint [5] 0 0
4 weeks
Secondary outcome [6] 0 0
Maximum change in mean NPRS - To determine the maximum effects of oral LAT8881 in neuropathic pain, compared with placebo.
Timepoint [6] 0 0
1,2,3 or 4 weeks
Secondary outcome [7] 0 0
Change in functioning as assessed by the Brief Pain Inventory Interference Scale (BPI) - 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.
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Change in pain characteristics and intensity, as assessed by the Short Form McGill Pain Questionnaire- (SF-MPQ-2) - 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.
Timepoint [8] 0 0
4 weeks
Secondary outcome [9] 0 0
Change in neuropathic pain symptoms, as assessed by Neuropathic Pain Symptom Inventory (NPSI) - To evaluate the effect of oral LAT8881, compared with placebo, on symptoms in subjects with neuropathic pain, when measured by the NPSI.
Timepoint [9] 0 0
4 weeks
Secondary outcome [10] 0 0
Change in emotional functioning, as assessed by the Beck Depression Inventory-II - To evaluate the effect of oral LAT8881, compared with placebo, on emotional functioning when measured by the Beck Depression Inventory-II (BDI-II).
Timepoint [10] 0 0
4 weeks
Secondary outcome [11] 0 0
Patient Global Impression of Change Score - 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,.
Timepoint [11] 0 0
4 weeks
Secondary outcome [12] 0 0
Rescue medication use - To determine the change from baseline in paracetamol rescue medication use during oral LAT8881 administration, compared with placebo.
Timepoint [12] 0 0
Weekly over four-week treatment
Secondary outcome [13] 0 0
Pharmacokinetics of twice daily oral LAT8881 - Pharmacokinetic parameters in PK subjects :
Maximum Plasma Concentration (Cmax) Time at which Maximum Plasma Concentration is observed (Tmax)
Timepoint [13] 0 0
up to 4 weeks of treatment
Secondary outcome [14] 0 0
Pharmacokinetics of twice daily oral LAT8881 - Pharmacokinetic parameters in PK subjects :
Area Under the Curve (AUC)
Timepoint [14] 0 0
up to 4 weeks of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Medical Research - Hurstville
Recruitment hospital [2] 0 0
AusTrials - Brisbane
Recruitment hospital [3] 0 0
Emeritus Research Services - Melbourne
Recruitment postcode(s) [1] 0 0
2220 - Hurstville
Recruitment postcode(s) [2] 0 0
4075 - Brisbane
Recruitment postcode(s) [3] 0 0
3124 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lateral Pharma Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03865953
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Pickering, PhD, MB ChB
Address 0 0
University of Bristol
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicky Wallis
Address 0 0
Country 0 0
Phone 0 0
+61 438 020 177
Fax 0 0
Email 0 0
nwallis@lateral-pharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03865953