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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05298306
Registration number
NCT05298306
Ethics application status
Date submitted
3/03/2022
Date registered
28/03/2022
Date last updated
28/07/2023
Titles & IDs
Public title
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
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Scientific title
A Two-part Proof-of-Concept Study Assessing the Safety and Efficacy of LAT8881 in Lumbar Radicular Pain
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Secondary ID [1]
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LAT-NP-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Radiculopathy Lumbar
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LAT8881
Treatment: Drugs - Placebo
Experimental: LAT8881 - In Part A, LAT8881 will be given as a single intravenous infusion on separate days at doses of 0.8, 1.2 and 1.8 mg/kg.
In Part B, LAT8881 will be given as a single intravenous infusion. The dose will be determined from the results of Part A.
Placebo comparator: Placebo - Matching placebo will be given as a single intravenous infusion in Part A and Part B
Treatment: Drugs: LAT8881
In Part A, LAT8881 will be given as a single intravenous infusion at doses of 0.8, 1.2 and 1.8 mg/kg.
In Part B, a single intravenous infusion of LAT8881 will be given, the dose to be determined by the results in Part A
Treatment: Drugs: Placebo
Matching placebo'given as a single intravenous infusion at all dose levels
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of participants with adverse events by dose (Part A)
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Assessment method [1]
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The number of participants in Part A with the following adverse events will be reported by dose (with all placebo subjects combined)
* All adverse events
* Serious adverse events
* Adverse events leading to premature discontinuation of Investigational Medicinal Product (IMP)
* Adverse events by intensity
* Adverse events by relationship to IMP
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Timepoint [1]
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From first dose of LAT8881 to end of study visit (Day 14)
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Primary outcome [2]
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Change in baseline pain with intravenous LAT8881 in patients with lumbar radicular pain (Part B)
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Assessment method [2]
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Change in pain from baseline is measured on on a 0-10 Visual Analogue Scale (VAS). The VAS consists of a 10 cm line with two endpoints representing 0 (no pain) and 10 (pain as bad as it could possibly be). The subject is asked to rate their current level of pain by placing a mark on the line and the distance from 0 is measured to provide a pain intensity score out of 10.
VAS measurements are taken as the infusion starts and at 15 minute intervals for the first hour, then every thirty minutes for an additional two hours, then hourly until 6 hours from infusion commencement
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Timepoint [2]
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From start of infusion to 6 hours after start of infusion
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Secondary outcome [1]
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Maximum plasma LAT8881 concentration (Cmax) after intravenous LAT8881 (Part A)
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Assessment method [1]
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LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration
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Timepoint [1]
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Up to 6 hours after the start of each infusion
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Secondary outcome [2]
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Time to maximum plasma LAT8881 concentration (Tmax) after intravenous LAT8881 (Part A)
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Assessment method [2]
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LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration
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Timepoint [2]
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Up to 6 hours after the start of each infusion
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Secondary outcome [3]
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Area Under the Concentration Time Curve From Zero to Infinity (AUC0-inf) after intravenous LAT8881 (Part A)
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Assessment method [3]
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LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration. (AUC0-inf) will only be calculated if there are at least three quantifiable data points
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Timepoint [3]
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Up to 6 hours after the start of each infusion
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Secondary outcome [4]
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Terminal elimination half life (T1/2), (Part A)
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Assessment method [4]
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LAT8881 is measured in plasma samples taken pre-dose and at 5 minutes, 0.25, 0.5, 1, 2, 4 and 6 hours after IMP administration. The terminal elimination half life will only be determined if there are at least three quantifiable elimination phase data points.
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Timepoint [4]
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Up to 6 hours after the start of each infusion
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Secondary outcome [5]
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Patient general impression of change (Part B)
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Assessment method [5]
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The Patient General 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.
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Timepoint [5]
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6 hours after the start of the second infusion
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Secondary outcome [6]
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The number of participants with adverse events after intravenous LAT8881 in patients with lumbar radicular pain (Part B)
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Assessment method [6]
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The number of participants in Part B with the following adverse events will be reported after placebo and after intravenous LAT8881
* All adverse events
* Serious adverse events
* Adverse events leading to premature discontinuation of Investigational Medicinal Product (IMP)
* Adverse events by intensity
* Adverse events by relationship to IMP
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Timepoint [6]
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From start of infusion to end of study visit (Day 9)
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Eligibility
Key inclusion criteria
Key
For PART A, the following inclusion criteria apply:
* Male or female healthy participants, aged 18-49 years inclusive at screening;
* Body mass index of = 19.0 kg/m2 to = 32.0 kg/m2 at screening;
* Female participants must not be pregnant or breastfeeding
* Male participants with a female partner of childbearing potential must use highly effective contraception for 60 days after the last dose of study treatment
For PART B, the following key inclusion criteria apply:
* Male or female participants with unilateral pain, aged 18 years and above at screening;
* Body mass index of = 19.0 kg/m2 at screening.
* Female participants must not be pregnant or breastfeeding
* Male participants with a female partner of childbearing potential must use highly effective contraception for 60 days after the last dose of study treatment
* Presenting with a history of unilateral pain, radiating into a lower limb, of lancinating, burning, stabbing or electric quality, of duration of >3 months.
* Pain scores (VAS) for average daily leg pain at rest at the relevant nerve root of a mean of =4/10 and =9/10 for 3 days prior to treatment, with a minimum of >3/10 on any day.
* Demonstration of disc herniation within 6 months by CT or MRI at a segmental level consistent with the clinical features.
* The site of disc herniation must affect L1-2, L2-3, L3-4, L4-5 or L5-S1.
* The patient is willing to keep all analgesic medication and other therapy usage stable or decreased in the week prior to, and a week after, IP administration.
* The patient is in good general health, with the exception of the presenting condition under study
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Minimum age
18
Years
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
The following key exclusion criteria apply for both PART A and PART B:
* Any condition which might be a risk to participant safety or interfere with study evaluation
* Unwillingness to abstain from alcohol or nicotine products as required
The following additional key exclusion criteria apply to PART B:
* A history of significant pain unrelated to disc herniation that would significantly compromise assessment of leg radicular pain.
* Radiological evidence of foraminal stenosis or of clinically significant spinal stenosis .
* Lumbar back surgery related to the specific disc.
* Injection of an epidural corticosteroid injection within 3 months of screening.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/06/2023
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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PARC Clinical Research - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Lateral Pharma Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Southern Star Research Pty Ltd.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The study consists of two parts. Part A will evaluate the safety and tolerability of intravenous LAT8881 in healthy volunteers using an ascending dose schedule. Part B will evaluate the analgesic efficacy of a single intravenous dose of LAT8881, compared with placebo, in patients with lumbar radicular pain. Healthy volunteers are not accepted for Part B.
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Trial website
https://clinicaltrials.gov/study/NCT05298306
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Guy Ludbrook, MBBS
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Address
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Royal Adelaide Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05298306
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