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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000201471

Acronym

N/A

Enrollment

Registered

2007-04-12

Start date

2007-04-10

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Patients will receive ACV1 at a dose of 0.4 mg/kg, injected subcutaneously once per day for 21 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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 criteria

Cardiac abnormality.Hypotension or hypertension.Organ dysfunction.Pain anywhere else of an equal or greater intensity of the neuropathic pain.

Outcome results