None listed
Conditions
Brief summary
ACV1 was discovered in the venom of an Australian marine cone snail. It blocks a type of receptor in the peripheral nervous system, which may then have a pain decreasing effect in types of neuropathic pain (nerve pain). Neuropathic pain is the category of pain having the greatest need for improved drugs. This trial is in patients with sciatica, which is caused by damage or compression of the sciatic nerve which runs from the lower spine down both legs. The trial aims to examine whether giving ACV1 to these patients provides pain relief.
Interventions
Subcutaneous injections of 0.4mg/kg ACV1 once daily for 7 days, followed by a 7 day washout then crossover treatment
Sponsors
Metabolic Pharmaceuticals
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1.Ability to provide written informed consent.2. Non child-bearing potential (surgically sterilised, hysterectomised or post-menopausal, determined as = 45 years of age and amenorrhea for > 12 months). 3.Neuropathic sciatic pain as evidenced by presence of moderate to severe spontaneous neuropathic pain (based on Visual Analogue Scale (VAS) = 4cm) pain in one or both buttocks or legs for 3 months or greater for at least 5 days a week plus at least one of the following;a.Sharp & shooting pain below the kneeb.Pain evoked by Straight Leg Raising (SLR) to 60 degrees or lessc.Decreased or absent ankle reflexes.Weakness of muscles below the kneee.Sensory loss in L5/S1 distribution (assessed by pinprick, light touch, vibration and joint movement. 4.If on concurrent medications for sciatic pain, medications and doses must have been stable for 4 weeks prior to Day 1. 5. Weight < 120 kg. 6.Adequate venous access in arms to allow collection of a number of blood samples. 7.Ability to read and understand English in order to complete the assessment scales.
Exclusion criteria
1.Any history of clinically significant cardiac arrhythmias or the presence of clinically significant abnormalities on ECG at screening.2.Any evidence or history of hypotension or hypertension. Hypotension is defined as three separate readings that persistently read under 90/60 mmHg. Hypertension is defined as three separate readings that persistently read over 140/90 mmHg.3.Tumours or fractures as the cause of pain.4.Diabetes as defined as fasting blood glucose levels = 7mM.5.A history or evidence of any other clinical neuropathy.6.Diagnosed Rheumatoid Arthritis.7.Pain anywhere else of an equal or greater intensity than the sciatica-related pain.8.Admission for Heart Failure, a Myocardial Infarction, Transient Ischaemic Attack or Cerebrovascular Accident within the 6 months prior to Day 1.9.Patients with a clinical condition that may, in the opinion of the Investigator, impact on the patient’s ability to participate in the study, or on the study results10.A calculated creatinine clearance of less than 75 mL/min.11.Documented or reported history of Hepatitis B, Hepatitis C, or HIV infection. NOTE – these will not be tested for.12.Any evidence of organ dysfunction, or any deviation in clinical laboratory values which is confirmed on re-examination to be clinically significant (i.e. in the opinion of the Investigator would jeopardise the safety of the patient or impact on the validity of the study results), including a liver function test (LFT) > 1.5 x upper limit of normal (ULN). Total bilirubin levels > 1.5 x ULN will be allowed if associated with Gilbert’s syndrome.13.History of, or current evidence of, abuse (in the investigator’s opinion) of alcohol or any licit or illicit drug substance.14.Known poor compliers or those unlikely to attend study visits.15.Receipt of any drug as part of a research study within 30 days of Day 1.16.Standard blood donation (usually 550 mL) within the 12-week period prior to Day 1.
Outcome results
None listed