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

NCT00321672 | Completed Phase 3 Results

• 1 other identifier: C119
• Study Type: interventional
• Target: 494
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain; HIV Infections; Peripheral Nervous System Diseases

Keywords

Analgesics; Capsaicin; Neuropathic pain; Neuropathy; Distal sensory polyneuropathy; Peripheral neuropathy; Dermal assessment; Pain measurement

Outcome Measures

Primary Outcomes (1)

• 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.

  Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing "average pain for the past 24 hours" for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.

  Weeks 2-12

Secondary Outcomes (2)

• 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.

  Weeks 2-12.

• 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

  Weeks 2-12

Study Arms (4)

NGX-4010, 60 minutes

EXPERIMENTAL

Drug: NGX-4010, 8% capsaicin patch

NGX-4010, 30 minutes

EXPERIMENTAL

Drug: NGX-4010, 8% capsaicin patch

0.04% conc. capsaicin patch, 60 min.

OTHER

Drug: 0.04% capsaicin patch

0.04% conc. capsaicin patch, 30 min.

OTHER

Drug: 0.04% capsaicin patch

Interventions

NGX-4010, 8% capsaicin patch DRUG

Up to 4 NGX-4010 patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.

Also known as: the brandname of NGX-4010, 8% capsaicin patch is Qutenza.

NGX-4010, 60 minutes

0.04% capsaicin patch DRUG

Up to 4 control patches of 280 cm\^2 each were applied to the feet (2 per foot) for 60 minutes.

Also known as: NGX-4010

0.04% conc. capsaicin patch, 60 min.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeurogesX: lead

Related Publications (2)

• Brown S, Simpson DM, Moyle G, Brew BJ, Schifitto G, Larbalestier N, Orkin C, Fisher M, Vanhove GF, Tobias JK. NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials. AIDS Res Ther. 2013 Jan 28;10(1):5. doi: 10.1186/1742-6405-10-5.

  PMID: 23351618 DERIVED

• Clifford DB, Simpson DM, Brown S, Moyle G, Brew BJ, Conway B, Tobias JK, Vanhove GF; NGX-4010 C119 Study Group. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr. 2012 Feb 1;59(2):126-33. doi: 10.1097/QAI.0b013e31823e31f7.

  PMID: 22067661 DERIVED

MeSH Terms

Conditions

Pain; HIV Infections; Peripheral Nervous System Diseases; Neuralgia

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

Differences between the 60- and 30-minute Control groups prevented pooling according to prespecified criteria resulting in treatment comparisons between 60- and 30-minute NGX-4010 groups and their respective Control groups with relatively low power.

Results Point of Contact

• Title: Trudy Vanhove, VP Clinical Development
• Organization: NeurogesX

tvanhove@neurogesx.com

650-393-7444

Study Officials

• Trudy F Vanhove, MD

  NeurogesX

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 4, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 14, 2011
• Results First Posted: June 14, 2011

Record last verified: 2011-05