AT881 in Neuropathic Pai

Phase 1

• Conditions: europathic pain (NP), associated with either postherpetic neuralgia (PHN) or diabetic peripheral neuropathy (DPN); MedDRA version: 21.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004534-15-GB
• Lead Sponsor: ateral Pharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-25
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

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:
a)symmetrical, bilateral pain in the lower extremities for at least 3 months and
b)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
c)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:
a)painDETECT questionnaire (PD-Q) and
b)Clinical assessment, showing signs of neuropathic pain in either a dermatomal (PHN) or distal symmetrical distribution (DPN)
4.Aged 18 to 75 years
5.Subjects must be sufficiently competent in English to understand the purposes and risks of the study and able to give voluntary written informed consent to participate in the study
6.Willing and able to comply with all study procedures
7.Completion of at least five NPRS scores during the week preceding randomisation
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
9.No more than one score on the NPRS of 9 or more, and no more than one score of 2 or less, in the last five diary entries before randomisation
10.Females of child bearing potential must have a negative pregnancy test at Visit 1 (Screening) and at Visit 2 (Day 1) prior to administration of IMP
11.Female subjects must be:
a)of non child-bearing potential [surgically sterilised or post–menopausal (12 months with no menses without alternative medical cause)] OR
b)not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 28 days after the last IMP administration

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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
3.Skin conditions in the affected area that could alter sensation or assessments
4.History of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunological, neurological, ophthalmological, haematological or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardise the safety of the subject or the validity of the study results
5.Medical history of, or currently active, human immunodeficiency virus, hepatitis B or hepatitis C virus
6.Clinically significant abnormal 12-lead electrocardiogram (ECG) at screening
7.Immunocompromised state, or conditions known to be associated with an immunocompromised state
8.Clinically significant or unstable medical or psychological condition that would compromise participation in the study
9.Recent history of malignancy within 5 years preceding screening (except resected cervical or skin cancer [except melanoma]). Subjects who have had no evidence of disease in the last 5 years are eligible
10.Active herpes zoster infection on screening
11.Current alcohol abuse, illicit or illegal drug use
12.Use of prohibited medication (see study medications)
13.Previous treatment with LAT8881 (formerly identified as AOD9604) within the last 5 years
14.Participation in an investigational trial within 60 days or 5 half-lives (whichever is longer) prior to screening
15.History of significant hypersensitivity to LAT8881 or drugs of a similar pharmacological class (e.g. somatropin)
16.Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
17.An employee of the sponsor or research site personnel directly affiliated with this study, whether biological or legally adopted, or their immediate family members, defined as a spouse, parent, sibling, or child
18.Previous neurolytic or neurosurgical therapy for PHN or DPN
19.PK subjects:
a)Blood or plasma donation of more than 500 mL during the 3 months prior to randomisation
b)History of fainting during phlebotomy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified