Symptoms and General Pathology

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Nervous System Diseases

Cancer Pain

Pain

Pain, Intractable

Neurologic Manifestations

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Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Enkephalins

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.

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.

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.

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.

Placebo

Darren Wolfe, Ph.D.

David Fink, M.D.

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.

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.

NP2 Enkephalin For Treatment of Intractable Cancer Pain

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

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

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

•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.

•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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NP2 Enkephalin For Treatment of Intractable Cancer Pain	NCT01291901	Intractable Pai... Neoplasms	NP2 Placebo	18 Years -	Diamyd Inc
NP2 Enkephalin For Treatment of Intractable Cancer Pain	NCT01291901	Intractable Pai... Neoplasms	NP2 Placebo	18 Years -	Diamyd Inc
NP2 Enkephalin For Treatment of Intractable Cancer Pain	NCT01291901	Intractable Pai... Neoplasms	NP2 Placebo	18 Years -	Diamyd Inc

Spots Global Cancer Trial Database for intractable

Every month we try and update this database with for intractable cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for intractable

Every month we try and update this database with for intractable cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for intractable cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.