RecruitingPhase 2ACTRN12606000403538
Investigation of AV411 in neuropathic pain
A prospective, double-blind, randomized, placebo-controlled trial of AV411 to assess its safety tolerability, pharmacokinetics and preliminary efficacy in the treatment of neuropathic pain
Sponsor
Avigen, Inc.
Enrollment
36 participants
Start Date
Sep 15, 2006
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss
Inclusion Criteria1
- 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 Criteria1
- 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 <100,000 mm3 or a history of thrombocytopenia.-Known or suspected chronic liver disease.-GFR <= 90 mL/min/1.73m2 (Cockcroft-Gualt).-Female subjects who are pregnant or nursing mothers.-Received an investigational drug in the past 90 days.-Unable to swallow large capsules.
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Interventions
Oral AV411 (20, 30, or 40 mg) two or three times daily for 24 days
Oral AV411 (20, 30, or 40 mg) two or three times daily for 24 days
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000403538