Status:
COMPLETED
Oral LAT8881 in Neuropathic Pain
Lead Sponsor:
Lateral Pharma Pty Ltd
Conditions:
Neuropathic Pain
Diabetic Peripheral Neuropathy (DPN)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
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, subject...
Eligibility Criteria
Inclusion
- Clinical diagnosis of post herpetic neuralgia, with pain persisting for at least 3 months after the onset of herpes zoster rash OR
- Clinical diagnosis of distal painful polyneuropathy due to Type I or Type II diabetes mellitus with:
- symmetrical, bilateral pain in the lower extremities for at least 3 months and
- 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
- no change in diabetic medication planned for the duration of the study
- Positive sensory symptoms (mechanical or thermal) associated with neuropathic pain, confirmed by:
- painDETECT questionnaire (PD-Q) and
- 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
Exclusion
- Presence of moderate to severe pain from other causes that may confound assessment or self-evaluation of NP.
- Subjects with both DPN and PHN
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03865953
Start Date
April 9 2019
End Date
May 3 2020
Last Update
June 14 2021
Active Locations (6)
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1
Paratus Clinical Research Kanwal
Kanwal, New South Wales, Australia, 2259
2
Paratus Clinical Research Blacktown
Sydney, New South Wales, Australia, 2148
3
AusTrials
Brisbane, Queensland, Australia, 4075
4
Emeritus Research Services
Melbourne, Victoria, Australia, 3124