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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: Pain; HIV Infections; Peripheral Nervous System Diseases

Intervention: NGX-4010, 8% capsaicin patch (Drug); 0.04% capsaicin patch (Drug); NGX-4010, 8% capsaicin patch (Drug); 0.04% capsaicin patch (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: NeurogesX

Official(s) and/or principal investigator(s):
Trudy F Vanhove, MD, Study Director, Affiliation: NeurogesX


The purpose of the study was to assess the efficacy and safety of NGX-4010 applied for 30 or 60 minutes for the treatment of painful HIV-associated neuropathy.

Clinical Details

Official title: A Multicenter Randomized, Double-Blind, Controlled Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Primary Measure of Efficacy Was the Percent Change in the "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.

Secondary outcome:

Absolute Change in the Mean "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.

Proportion of Subjects Reaching 30% Decrease in Their Mean "Average Pain for the Past 24 Hours" Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12

Detailed description: Study C119 was a multicenter, randomized, double-blind, controlled evaluation of the efficacy and safety of NGX-4010 for the treatment of painful HIV-associated neuropathy. Eligible subjects had painful HIV-associated neuropathy resulting from HIV disease and/or antiretroviral drug exposure in both feet, with average numeric pain rating scale (NPRS) scores during screening of 3 to 9 (inclusive). Up to four patches covering an area of up to 1120 square centimeters could be used during a single treatment administration in this study. Subjects were randomly assigned to receive active NGX-4010 patches (8% capsaicin) or low-concentration control patches (0. 04% capsaicin) identical in appearance, at doses (patch application duration) of either 30 or 60 minutes, according to a 2: 1:2: 1 allocation scheme. Subjects could be on stable chronic oral pain medication regimens, but could not be using any topical pain medications on the affected areas. NPRS scores for the average pain in the past 24 hours were recorded daily in the evening, beginning on the day of the Screening

Visit (usually on Day - 14). Subjects continued to record NPRS scores in a take-home diary

from the evening on the day of treatment through the evening before the Termination Visit at Week 12. Subjects returned for interim follow-up visits at Weeks 4 and 8 following study treatment.


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


Inclusion Criteria:

- Documented evidence of HIV-1 infection

- Documented diagnosis of painful HIV-associated distal symmetric polyneuropathy

resulting from HIV disease and/or antiretroviral drug exposure To be confirmed based on 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 OR at least one of following: distal diminution of vibration sensation or pain or temperature sensation in legs

- Average NPRS scores during screening period of 3 to 9, inclusive

- Life expectancy of 12 months or longer per Investigator's judgment

- Intact, unbroken skin over painful areas to be treated

- If taking chronic pain medications, be on stable regimen for at least 21 days prior

to Day 0 and willing to maintain medications at same stable dose(s) and schedule throughout 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 conception

process during study and for 30 days following study drug exposure

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

Exclusion Criteria:

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

exceeding total daily dose of morphine 80 mg/day or equivalent; parenteral opioids not allowed

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

unwillingness to use opioid analgesics during study treatment or high tolerance to opioids precluding ability to relieve treatment-associated discomfort as judged by investigator

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

prior chronic substance abuse (including alcoholism) judged likely to recur during study period by investigator

- Recent use (within 21 days preceding Day 0) of any topically applied pain medication,

such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin products on painful areas

- Started or stopped treatment with one or more neurotoxic antiretroviral agents (ie,

didanosine [ddI], zalcitabine [ddC], or stavudine [d4T] during 8 weeks prior to Day 0

- Participation in previous clinical trial in which subject received either blinded or

open-label NGX-4010

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

tocainide and mexiletine)

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

uncontrolled diabetes mellitus (HbA1c≥9%) or history of diabetes mellitus preceding onset of HIV-associated neuropathy (HIV-AN); hereditary neuropathy; vitamin B12 deficiency (B12 level ≤200pg/mL at screening); or treatment within 90 days prior to Screening Visit with any drug that may have contributed to sensory neuropathy

- Hypertension, unless adequately controlled by medication

- Significant ongoing pain from other cause(s) that may interfere with judging HIV-AN

related pain

- Any implanted medical device for treatment of neuropathic pain

- Hypersensitivity to capsaicin (i. e., chili peppers or over-the-counter (OTC)

capsaicin products), local anesthetics, opioid-based oral analgesics or adhesives

- Significant medical conditions (including active malignancy defined as treatment

required in last 5 years) that in opinion of investigator would interfere with ability to complete study or evaluation of AEs

- Recent significant medical-surgical intervention that in judgment of Investigator

would interfere with ability to complete study or evaluation of AEs; examples include to major surgery, or receipt of immunosuppressive therapy within 3 months prior to Day 0

- Evidence of cognitive impairment including dementia that may interfere with subject's

ability to complete daily pain diaries requiring recall of average HIV-associated neuropathy pain level in past 24 hours

Locations and Contacts

Additional Information

Starting date: June 2006
Last updated: May 13, 2011

Page last updated: August 20, 2015

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