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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03865953
Ethics application status
Date submitted
2/03/2019
Date registered
7/03/2019

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 Peripheral Neuropathy (DPN) 0 0
Post Herpetic Neuralgia (PHN) 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
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)
Timepoint [1] 0 0
Baseline to Week 4
Secondary outcome [1] 0 0
Change in NPRS Score After the First and Last Dose of LAT8881 and Placebo
Timepoint [1] 0 0
Pre-dose, 0.5,1,2,4 and 6 hours after the first and last dose of LAT8881 and placebo
Secondary outcome [2] 0 0
Change in Mean Pain Scores After 1, 2 and 3 Weeks of Treatment, Using NPRS
Timepoint [2] 0 0
1,2 and 3 weeks
Secondary outcome [3] 0 0
30% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.
Timepoint [3] 0 0
4 weeks
Secondary outcome [4] 0 0
50% Responder Rate in Oral LAT8881 Compared With Placebo, as Assessed by the Numeric Pain Rating Scale.
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Maximum Change in Mean NPRS
Timepoint [5] 0 0
1,2,3 or 4 weeks
Secondary outcome [6] 0 0
Change in Functioning as Assessed by the Brief Pain Inventory Interference Scale (BPI)
Timepoint [6] 0 0
4 weeks
Secondary outcome [7] 0 0
Change in Pain Characteristics and Intensity, as Assessed by the Short Form McGill Pain Questionnaire (SF-MPQ-2)
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI)
Timepoint [8] 0 0
4 weeks
Secondary outcome [9] 0 0
Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II
Timepoint [9] 0 0
4 weeks
Secondary outcome [10] 0 0
Patient Global Impression of Change Score
Timepoint [10] 0 0
4 weeks
Secondary outcome [11] 0 0
Rescue Medication Use
Timepoint [11] 0 0
Weekly over four-week treatment
Secondary outcome [12] 0 0
Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881
Timepoint [12] 0 0
Day 1 and Day 28
Secondary outcome [13] 0 0
Time to Maximum Plasma Concentration of LAT8881 (Tmax)
Timepoint [13] 0 0
Day 1 and day 28
Secondary outcome [14] 0 0
Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf)
Timepoint [14] 0 0
Day 1 and Day 28

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 numeric pain rating scale (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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2020
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Kanwal - Kanwal
Recruitment hospital [2] 0 0
Paratus Clinical Research Blacktown - Sydney
Recruitment hospital [3] 0 0
AusTrials - Brisbane
Recruitment hospital [4] 0 0
Emeritus Research Services - Melbourne
Recruitment postcode(s) [1] 0 0
2259 - Kanwal
Recruitment postcode(s) [2] 0 0
2148 - Sydney
Recruitment postcode(s) [3] 0 0
4075 - Brisbane
Recruitment postcode(s) [4] 0 0
3124 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Bristol
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an Early Proof of Concept study


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03865953