Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy

Condition(s) targeted: Painful Diabetic Neuropathy

Intervention: placebo (Drug); topical clonidine (ARC-4558) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Arcion Therapeutics Inc

The purpose of this study is to determine whether ARC-4558 is effective in managing pain associated with painful diabetic neuropathy.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Primary outcome: mean change from Baseline in NPRS score

Secondary outcome:

mean change from Baseline in NPRS score at each week

Percentage of subjects who experience at least 30% or at least 50% reduction in pain intensity from Baseline to each week of treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- has Type 1 or Type 2 diabetes mellitus

- has a history of chronic pain attributable to a symmetrical stocking distribution

neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening

Exclusion Criteria:

- has neuropathy secondary to non-diabetic causes

- has a significant neurological disorder or a condition that can cause symptoms that

mimic peripheral neuropathy or might confound assessment of PDN

- has other chronic pain with intensity at or greater than the bilateral pain in the

feet/toes

- is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or

peripheral nerve stimulator) for the treatment of pain

- is pregnant or lactating

University of Alabama at Birmingham, School of Medicine, Birmingham, Alabama 35294, United States; Recruiting
Marianne Vetrano, Phone: 205-934-4379
Tiffany Grimes, Phone: (205) 934-4379
Fernando Ovalle, MD, Principal Investigator

Northern California Research, Carmichael, California 95608, United States; Recruiting
Laurie Johnson, CCRC, Phone: 916-484-0500
Douglas Young, MD, Principal Investigator

Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States; Recruiting
Pat O'Reilly, Phone: 504-988-4651
Vivian Fonseca, MD, Principal Investigator

University of Massachuetts Medical School, Division of Diabetes- Clinical Research Office, Worcester, Massachusetts 01655, United States; Recruiting
Celia Hartigan, RN/MPH/CCRC, Phone: 508-334-7628
Samir Malkani, MD, Principal Investigator

University of Rochester Medical Center, Rochester, New York 14642, United States; Recruiting
Lisa Bailey, RN, Phone: 585-273-5199
Robert Dworkin, PhD, Principal Investigator

The Center for Clinical Research, Winston-Salem, North Carolina 27103, United States; Recruiting
Joan Southern, Phone: 336-765-6181
Richard Rauck, MD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Toula Bensitel, Phone: 216-444-9674
Nagy Mekhail, MD, Principal Investigator

Waccamaw Pain Partners/Crescent Moon Research, Murrells Inlet, South Carolina 29576, United States; Recruiting
Elizabeth Parler, Phone: 843-652-0222
Jason C Rosenberg, MD, Principal Investigator

Diabetes and Glandular Disease Center, San Antonio, Texas 78229, United States; Recruiting
Todd Siluck, Phone: 210-426-3700, Ext: 6807
Mark Kipnes, MD, Principal Investigator

Strelitz Diabetes Institute, Eastern Virginia Medical School, Norfolk, Virginia 23510, United States; Recruiting
Tonya Clayton, Phone: 757-446-5106
Pat Barlow, Phone: (757) 446-7258
Aaron Vinik, MD, Principal Investigator

Starting date: May 2008
Ending date: July 2009
Last updated: October 31, 2008