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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)
Assessment method [1] 0 0
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.
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
Assessment method [1] 0 0
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.
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
Assessment method [2] 0 0
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.
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.
Assessment method [3] 0 0
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.
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.
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
4 weeks
Secondary outcome [5] 0 0
Maximum Change in Mean NPRS
Assessment method [5] 0 0
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..
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)
Assessment method [6] 0 0
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.
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)
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
4 weeks
Secondary outcome [8] 0 0
Change in Neuropathic Pain Symptoms, as Assessed by Neuropathic Pain Symptom Inventory (NPSI)
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
4 weeks
Secondary outcome [9] 0 0
Change in Emotional Functioning, as Assessed by the Beck Depression Inventory-II
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
4 weeks
Secondary outcome [10] 0 0
Patient Global Impression of Change Score
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
4 weeks
Secondary outcome [11] 0 0
Rescue Medication Use
Assessment method [11] 0 0
To determine the change from baseline in paracetamol rescue medication use during oral LAT8881 administration, compared with placebo.
Timepoint [11] 0 0
Weekly over four-week treatment
Secondary outcome [12] 0 0
Maximum Plasma Concentration of LAT8881 (Cmax) After Oral LAT8881
Assessment method [12] 0 0
Cmax is calculated after the first dose of IMP on Day 1 and after 4 weeks treatment on the morning of Day 28
Timepoint [12] 0 0
Day 1 and Day 28
Secondary outcome [13] 0 0
Time to Maximum Plasma Concentration of LAT8881 (Tmax)
Assessment method [13] 0 0
Tmax after the first dose of investigational medicinal product (IMP) and after 4 weeks treatment with IMP
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)
Assessment method [14] 0 0
AUC0-inf after the first dose of IMP and after 4 weeks of treatment
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


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