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Completed

NCT Number: NCT01291901

NP2 Enkephalin For Treatment of Intractable Cancer Pain

The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.

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Key information

Conditions

Intractable Pain Neoplasms Neurologic Manifestations Pain Pain, Intractable Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HOPE Research Institute, Phoenix, Arizona, United States

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About this study

Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Histologically confirmed malignant disease.
  • Intractable pain related to malignancy.
  • Females must be postmenopausal or practicing birth control.
  • Able to provide appropriate written consent.

Main Exclusion Criteria:

  • Positive pregnancy test prior to receiving study treatment.
  • Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).
  • Evidence of active Hepatitis B, Hepatitis C, or HIV infection.
  • Evidence of viral, bacterial, or fungal infection in the planned treatment area.

Treatment and study plan

NP2

Biological

NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

Placebo

Biological

The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.

Primary outcomes

  1. Pain Measured by the Numerical Rating Scale (NRS)

    Time frame: Days -5 to -1 predosing and days 3 to 14 postdosing

    • Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.

Secondary outcomes

  1. Opioid Pain Medication Usage Morphine Equivalent Units (MEU)

    Time frame: Days -5 to -1 predosing and 3 to 14 postdosing

    •Change from baseline of use of opioid pain medication average daily MEU of Placebo compared to Active NP2 cohorts

  2. Quality of Life ECOG

    Time frame: Baseline and Week 1, 2 and 4

    •Quality of Life measured by Eastern Cooperative Oncology Group Performance Status (ECOG) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.

  3. Quality of Life SF-12

    Time frame: Baseline and Week 1, 2 and 4

    •Quality of Life measured by the 12-Item Short Form Health Survey (SF-12v2) at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts.

  4. Pain SF-MPQ

    Time frame: Baseline and Week 1, 2 and 4

    •Short Form McGill Pain Questionnaire (SF-MPQ-2) assessment at follow-up visits compared to baseline of Placebo compared to Active NP2 cohorts

Sponsors and collaborators

Lead sponsor

Diamyd Inc

Industry

Collaborators

  • Paragon Biomedical
  • invivodata, Inc.

Registry information

Official study title

A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 9, 2011
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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