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Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

Information source: NeurogesX
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections; Peripheral Nervous System Diseases; Pain

Intervention: Capsaicin Dermal Patch (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NeurogesX

Official(s) and/or principal investigator(s):
David M Simpson, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Jeffrey Tobias, MD, Study Director, Affiliation: NeurogesX

Summary

The purpose of the study is to determine if an investigational drug, NGX-4010 (high-concentration capsaicin patch), is effective in treating painful HIV-associated neuropathy.

Clinical Details

Official title: A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Painful HIV-Associated Distal Symmetrical Polyneuropathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Percent change from baseline in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score (i.e., average of scores during Weeks 2-12, compared to baseline)

Secondary outcome:

Percent change from baseline in the "average pain for the past 24 hours" NPRS score (i.e., average of scores during Weeks 2-4 and 2-8, respectively, compared to baseline)

Proportion of subjects reaching 30% decrease from baseline in their "average pain for the past 24 hours" NPRS scores on average during Weeks 2-12, within each treatment group

Proportion of subjects reaching 30% decrease from baseline in their "average pain for the past 24 hours" NPRS scores on average during Weeks 2-4 and 2 8, respectively, within each treatment group

Percent change from baseline in the "worst pain for the past 24 hours" and "pain now" NPRS scores (baseline score compared to the average of scores from Weeks 2 -12), within each treatment group

"Pain now" on evening of treatment day

Mean onset and duration of efficacy in days within each treatment group

Proportion of subjects with significant changes in concomitant pain medication usage during Weeks 2-12, compared to baseline

Detailed description: The C107 study is a randomized, double-blind, controlled dose finding study of NGX-4010 for the treatment of painful symptoms of HIV-associated neuropathy. Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and to receive double-blind NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin). Participants who complete study evaluations through Week 12 will have the option of receiving up to 3 additional open-label treatments.

Eligibility

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

Criteria:

Inclusion Criteria:

- At least 18 years of age

- Documented evidence of HIV-1 infection

- Documented diagnosis of painful HIV-associated distal symmetrical polyneuropathy

established by a neurologist resulting from HIV disease and/or antiretroviral drug exposure, with primary symptoms of pain, burning or dysesthetic discomfort in both feet for at least 2 months prior to Screening Visit, and absent or diminished ankle reflexes, and at least one of the following: distal diminution of vibration sensation or pain or temperature sensation in the legs

- Either no neurotoxic antiretroviral (didanosine, zalcitabine or stavudine) exposure

for at least 8 weeks prior to Screening Visit, or currently on stable dose(s) of any neurotoxic antiretroviral(s) for at least 8 weeks prior to Screening Visit

- Screening Pain Sum Score of 12 to 36

- Karnofsky Performance Score of greater than or equal to 60

- Intact, unbroken skin over the painful area(s) to be treated

- If taking chronic pain medications, be on a stable (not PRN) regimen for at least 21

days prior to Treatment Visit and willing to maintain these medications at the same stable dose(s) and schedule throughout the study

- Female subjects with child-bearing potential: negative serum pregnancy test performed

at Screening Visit

- Willing to use effective methods of birth control and/or refrain from participating

in a conception process during study and for 30 days following experimental drug exposure

- Willing and able to comply with protocol requirements for duration of study

Exclusion Criteria:

- Concomitant opioid medication, unless orally or transdermally administered and not

exceeding a total daily dose of morphine 60 mg/day, or equivalent. Parenteral opioid use is excluded, regardless of dose

- Unavailability of an effective rescue medication strategy for the subject, such as

unwillingness to use opioid analgesics during treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with Roxicodone® or Vicodin®, as judged by the Investigator

- Active substance abuse or history of chronic substance abuse within the past year, or

prior chronic substance abuse judged likely to recur during the study period by the investigator

- Recent use (within 21 days preceding the Treatment Visit of any topically applied

pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including Lidoderm®), steroids or capsaicin products on the painful areas

- Current use of any investigational agent or Class 1 anti-arrhythmic drugs

- Significant pain of an etiology other than painful HIV-associated neuropathy;

significant ongoing pain from other cause(s) that may interfere with judging HIV-associated neuropathy pain

- Evidence of another contributing cause for peripheral neuropathy, e. g., diabetes

mellitus requiring medication control (i. e., oral hypoglycemics, insulin); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤ 200 pg/mL) or less than 3 months of B12 supplementation prior to Screening Visit; or treatment within 90 days prior to Screening Visit with any drug that may have contributed to the sensory neuropathy

- Any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral

nerve stimulator) for the treatment of neuropathic pain

- Treatment for acute opportunistic infections within 14 days before Treatment Visit

- Presence of acute, active opportunistic infection, except oral thrush; oral, genital,

or rectal herpes; and Mycobacterium avium bacteremia within 2 weeks prior to Screening Visit

- Currently have active malignant disease

- Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or

pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events

- Hypersensitivity to capsaicin (i. e., chili peppers or OTC capsaicin products), local

anesthetics, Roxicodone®, Vicodin®, or adhesives

Locations and Contacts

NeurogesX Investigational Site, Phoenix, Arizona 85006, United States

NeurogesX Investigational Site, Phoenix, Arizona 85023, United States

NeurogesX Investigational Site, Berkeley, California 94609, United States

NeurogesX Investigational Site, San Diego, California 92103, United States

NeurogesX Investigational Site, San Francisco, California 94117, United States

NeurogesX Investigational Site, Stanford, California 94305, United States

NeurogesX Investigational Site, West Hollywood, California 90069, United States

NeurogesX Investigational Site, Fort Lauderdale, Florida 33306, United States

NeurogesX Investigational Site, Miami, Florida 33133, United States

NeurogesX Investigational Site, Miami, Florida 33136, United States

NeurogesX Investigational Site, North Palm Beach, Florida 33408, United States

NeurogesX Investigational Site, Orlando, Florida 32804, United States

NeurogesX Investigational Site, Sunrise, Florida 33351, United States

NeurogesX Investigational Site, Vero Beach, Florida 32960, United States

NeurogesX Investigational Site, Honolulu, Hawaii 96816, United States

NeurogesX Investigational Site, Chicago, Illinois 60612, United States

NeurogesX Investigational Site, Lexington, Kentucky 40536, United States

NeurogesX Investigational Site, Baltimore, Maryland 21205, United States

NeurogesX Investigational Site, Boston, Massachusetts 02215, United States

NeurogesX Investigational Site, Springfield, Massachusetts 01107, United States

NeurogesX Investigational Site, Detroit, Michigan 48201, United States

NeurogesX Investigational Site, Minneapolis, Minnesota 55416, United States

NeurogesX Investigational Site, St. Louis, Missouri 63108, United States

NeurogesX Investigational Site, Camden, New Jersey 08103-1489, United States

NeurogesX Investigational Site, Albany, New York 12208, United States

NeurogesX Investigational Site, New York, New York 10021, United States

NeurogesX Investigational Site, New York, New York 10029, United States

NeurogesX Investigational Site, Chapel Hill, North Carolina 27599, United States

NeurogesX Investigational Site, Cleveland, Ohio 44106, United States

NeurogesX Investigational Site, Portland, Oregon 97209, United States

NeurogesX Investigational Site, Austin, Texas 78705, United States

NeurogesX Investigational Site, Dallas, Texas 75208, United States

NeurogesX Investigational Site, Houston, Texas 77030, United States

NeurogesX Investigational Site, San Antonio, Texas 78229, United States

NeurogesX Investigational Site, Madison, Wisconsin 53792-5132, United States

Additional Information

Starting date: August 2003
Last updated: March 4, 2008

Page last updated: August 20, 2015

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