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NP2 Enkephalin For Treatment of Intractable Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01291901
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : August 8, 2014
Sponsor:
Collaborators:
Paragon Biomedical
invivodata, Inc.
Information provided by (Responsible Party):
Diamyd Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intractable Pain Neoplasms Biological: NP2 Biological: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : November 2013

Arm Intervention/treatment
Experimental: Active NP2
Single intradermal dose of active NP2. An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
Biological: NP2
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 Comparator: Placebo
Single intradermal dose of placebo (vehicle). An open label study extension will offer up to two additional doses of active NP2 between weeks 4-10 following the previous dose.
Biological: Placebo
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291901


Locations
Show Show 18 study locations
Sponsors and Collaborators
Diamyd Inc
Paragon Biomedical
invivodata, Inc.
Investigators
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Study Director: Darren Wolfe, Ph.D. Diamyd Inc
Principal Investigator: David Fink, M.D. University of Michigan

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Responsible Party: Diamyd Inc
ClinicalTrials.gov Identifier: NCT01291901    
Other Study ID Numbers: NP2/P2/10/2
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: July 2014
Keywords provided by Diamyd Inc:
pain
cancer
malignancy
intractable
gene therapy
enkephalin
opioid
Additional relevant MeSH terms:
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Pain, Intractable
Pain
Neurologic Manifestations
Signs and Symptoms
Enkephalins
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs