An investigation of the safety and effect of ACV1 on neuropathic pain in patients with diabetic peripheral neuropathic pain or post-herpetic neuralgia.
A randomised, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of subcutaneous doses of ACV1 in patients with diabetic peripheral neuropathic pain or post-herpetic neuralgia.
Metabolic Pharmaceuticals Ltd.
70 participants
Apr 10, 2007
Interventional
Conditions
Summary
Neuropathic pain is a debilitating form of chronic pain that arises from nerve damage. Current treatments for neuropathic pain can have undesirable side-effects and are limited in their effectiveness. ACV1 is a small synthetic drug designed from a component of the venom of an Australian marine cone snail, and is being developed as a treatment for neuropathic pain. The aim of this study is to investigate whether ACV1 provides pain relief to patients with diabetic peripheral neuropathy or post-herpetic neuralgia.
Eligibility
Inclusion Criteria1
- Stable and controlled (haemoglobin A1c level less than 9.0% at screening) Type I or Type II diabetes mellitus, reporting at least 3 months of pain (VAS = 4cm for at least 5 days a week) due to DPN. OR, diagnosis of PHN, reporting at least 3 months of pain (VAS = 4cm for at least 5 days a week) since shingles vesicle crusting.Ability to provide written informed consent.
Exclusion Criteria1
- Cardiac abnormality.Hypotension or hypertension.Organ dysfunction.Pain anywhere else of an equal or greater intensity of the neuropathic pain.
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Interventions
Patients will receive ACV1 at a dose of 0.4 mg/kg, injected subcutaneously once per day for 21 days.
Locations(1)
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ACTRN12607000201471