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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064623
• Other study ID #: C107
• Status: Completed
• Phase: Phase 3
• First received: July 10, 2003
• Last updated: March 4, 2008
• Start date: August 2003
• Est. completion date: November 2005

Study information

• Verified date: March 2008
• Source: NeurogesX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• HIV Infections
• Nervous System Diseases
• Pain
• Peripheral Nervous System Diseases

Intervention

Drug:
• Capsaicin Dermal Patch

Locations

Country	Name	City	State
United States	NeurogesX Investigational Site	Albany	New York
United States	NeurogesX Investigational Site	Austin	Texas
United States	NeurogesX Investigational Site	Baltimore	Maryland
United States	NeurogesX Investigational Site	Berkeley	California
United States	NeurogesX Investigational Site	Boston	Massachusetts
United States	NeurogesX Investigational Site	Camden	New Jersey
United States	NeurogesX Investigational Site	Chapel Hill	North Carolina
United States	NeurogesX Investigational Site	Chicago	Illinois
United States	NeurogesX Investigational Site	Cleveland	Ohio
United States	NeurogesX Investigational Site	Dallas	Texas
United States	NeurogesX Investigational Site	Detroit	Michigan
United States	NeurogesX Investigational Site	Fort Lauderdale	Florida
United States	NeurogesX Investigational Site	Honolulu	Hawaii
United States	NeurogesX Investigational Site	Houston	Texas
United States	NeurogesX Investigational Site	Lexington	Kentucky
United States	NeurogesX Investigational Site	Madison	Wisconsin
United States	NeurogesX Investigational Site	Miami	Florida
United States	NeurogesX Investigational Site	Miami	Florida
United States	NeurogesX Investigational Site	Minneapolis	Minnesota
United States	NeurogesX Investigational Site	New York	New York
United States	NeurogesX Investigational Site	New York	New York
United States	NeurogesX Investigational Site	North Palm Beach	Florida
United States	NeurogesX Investigational Site	Orlando	Florida
United States	NeurogesX Investigational Site	Phoenix	Arizona
United States	NeurogesX Investigational Site	Phoenix	Arizona
United States	NeurogesX Investigational Site	Portland	Oregon
United States	NeurogesX Investigational Site	San Antonio	Texas
United States	NeurogesX Investigational Site	San Diego	California
United States	NeurogesX Investigational Site	San Francisco	California
United States	NeurogesX Investigational Site	Springfield	Massachusetts
United States	NeurogesX Investigational Site	St. Louis	Missouri
United States	NeurogesX Investigational Site	Stanford	California
United States	NeurogesX Investigational Site	Sunrise	Florida
United States	NeurogesX Investigational Site	Vero Beach	Florida
United States	NeurogesX Investigational Site	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
NeurogesX

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	"Pain now" on evening of treatment day
Secondary	Mean onset and duration of efficacy in days within each treatment group
Secondary	Proportion of subjects with significant changes in concomitant pain medication usage during Weeks 2-12, compared to baseline