Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain

Avigen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Diabetic Neuropathy

Treatments: Drug: AV411

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576277

AV411-010

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration
• VAS score of 4 cm or higher at Screening
• No clinical abnormality in laboratory and urine analyses
• Electrocardiogram within normal limits at Screening
• Negative pregnancy test on Study Day 1 for female subjects of childbearing potential
• On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment
• Willing to use barrier contraceptive during the period of the study

Exclusion criteria

• Known hypersensitivity to AV411 or its components
• Conditions which might affect drug absorption, metabolism or excretion
• Untreated mental illness, current drug addiction or abuse or alcoholism
• Donated blood in the past 90 days or have poor peripheral venous access
• Platelets <100,000mm3 or a history of thrombocytopenia
• Known or suspected chronic liver disease
• GFR <=90mL/min/1.73m2 (Cockcroft-Gault)
• Female subjects who are pregnant or nursing mothers
• Received an investigational drug in the past 90 days
• Unable to swallow large capsules

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind