Nervous System Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Neuralgia

Cancer Pain

Pain

Pain, Intractable

Neurologic Manifestations

Chronic Graft Versus Host Disease

Arturo Cuomo, M.D.

Francesco Perrone, M.D., Ph.D.

The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.

Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated

Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain

evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication

to verify a correlation between initial dose for BTcP and daily dose of baseline pain therapy

to verify a correlation between effective dose for BTcP and daily dose of baseline pain therapy (dose reported in morphine equivalents)

National Cancer Institute, Naples

Peripheral Nervous System Diseases

Neuromuscular Diseases

Channel Blockers

Analgesics

Neuroprotective Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Ziconotide

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Protective Agents

Analgesics, Non-Narcotic

intrathecal ziconotide starting at 2.4 micrograms/day, with titration daily to achieve adequate pain control up to maximum dose of 21.6 micrograms/day

ziconotide

Gennaro Russo, M.D.

Alessandro Morabito, M.D.

Neuropathic pain is difficult to control because it is only partially sensitive to opioid analgesics, and requires the addition of other therapies such as antidepressants and epileptics. Ziconotide is a drug that is used to treat neuropathic pain in patients who have had inadequate pain control with prior combination of medicines.

The purpose of this study is to evaluate the effects and the tolerability of intrathecal ziconotide in cancer patients suffering from severe neuropathic pain not controlled by previous therapies.

Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer

Phase II Study of Intrathecal Ziconotide for the Treatment of Neuropathic Pain in Patients With Cancer

Central Nervous System Depressants

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

Paragon Biomedical

invivodata, Inc.

Diamyd Inc

Dermatologic Agents

Capsaicin

phase I, single-site, non-randomized, open-label, dose-escalation study to determine the safety and efficacy of IT RTX in subjects with severe refractory pain due to advanced malignancy

Intrathecal Resiniferatoxin

John D Heiss, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information.

People at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures:

Pretreatment Visit

Before beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes:

* Electrocardiogram (EKG)
* Blood draw
* Urinalysis
* Neurological examinations
* Peak expiratory flow rate (PEFR)
* Eye examination
* MRI
* Urology assessment
* Pregnancy test, when appropriate
* Questionnaires to collect information on health, personality, mood, pain levels and symptoms.

  2-Day Hospitalization

Patients are hospitalized for 2 days for RTX injection and monitoring, as follows:

* RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body.
* Post-injection monitoring, including:
* Surveys about symptoms such as pain or weakness
* Neurological examinations
* Blood and CSF sampling
* EKG
* AEs

Outpatient followup

* Vitals
* Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection
* MRI scans of the head and back, Urology assessment and PEFR on day 15 after the injection
* Eye examination
* Follow-up phone calls monthly for 6 months

Pain continues to be a major problem in patients with advanced cancer. Resiniferatoxin (RTX), a potent member of the family of drugs that includes capsaicin, selectively and irreversibly destroys the neurons (or their axons) transmitting chronic pain sensation. Intrathecal injection of RTX in several animal species has demonstrated a high level of safety, specificity, and efficacy in treating severe pain. This first-in-human, dose-escalation study will investigate the intrathecal administration of RTX in cancer patients with severe pain.

PRIMARY OBJECTIVE:

To investigate the safety and efficacy of RTX administered intrathecally in subjects with severe refractory pain associated with advanced cancer.

STUDY POPULATION:

Up to 45 subjects will be accrued. Eligible subjects will be greater than or equal to 18 years of age, have a clinical and histological diagnosis of advanced malignancy, and have severe pain due to malignancy that is at or below the level of the chest and not adequately relieved by other pain control therapies.

DESIGN:

This is a single site, non-randomized, open-label, dose-escalation study using a modified Fibonacci scheme. The starting dose of RTX was 13 micrograms given as a 2 mL injection via an intra-spinal catheter over approximately 30 seconds followed by a 1 mL flush. Six subjects were dosed at this level and 3 were dosed at the 26 microgram dose level at the same volume of injectate, flush and injection time. Under the study design, RTX doses were to be increased in progressively smaller percentage increments with each dose-escalation to occur in sequential groups of 3 subjects until 1 escalation above the effective dose in 100% of subjects (ED100), completion of the 100 microgram dose level, or establishment of the maximum tolerated dose (MTD), whichever occurs first. The total duration of study participation for any subject will received a dose of 26 micrograms.

The amended RTX injection technique reduced the injection volume and increased the injection time to reduce the spread of RTX to above the T6 (sixth thoracic) vertebral level. The present technique is a 1 mL injection over 2 minutes (0.5 mL/minute) given via infusion pump, followed by flushing of the IT catheter with the minimum volume of sterile, preservative-free saline necessary to clear the internal volume of the catheter used for the injection. Three patients were treated at the new starting dose of 13 micrograms with the new injection technique. The next 3-patient cohort will received a dose of 26 micrograms. The subsequent subject dose tier will receive a dose of 44 micrograms consistent with the protocol s dose-escalation algorithm. Administering this dose will require an infusion volume of 1.76 mL of the present 25 micrograms/mL RTX formulation.

OUTCOME MEASURES:

The primary study outcome is the ED100, the MTD, or the maximum dose administered, whichever is achieved first during dose-escalation. The primary pain variable for determining the ED100 is the daily worst pain score averaged over a 7-day period during the 3 weeks before RTX dosing and during Days 8 through 14 after dosing. The numerical rating scale (NRS), administered verbally during a daily telephone interview, will be the primary pain assessment instrument. For a given subject, the treatment will be considered effective if the subject experiences a greater than or equal to 50% reduction in the mean daily worst pain score assessed by NRS (evaluated on Study Day 15). We may also consider RTX treatment to be successful if there is greater than or equal to 50% reduction in opiate intake, measured by morphine milligram equivalents (MME) per day, even if pain levels are unchanged after RTX treatment.

Secondary outcome measures will be other surveys of pain, including an assessment of worst daily pain by the visual analog scale, and assessments of function and quality of life.

Safety assessments will include hematology; serum clinical chemistry tests; cerebrospinal fluid examinations; physical, neurological, and eye examinations; reporting of adverse events; electrocardiograms; and findings on magnetic resonance imaging of the spine and brain.

Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer

A Phase I Study of the Intrathecal Administration of Resiniferatoxin for Treating Severe Refractory Pain Associated With Advanced Cancer

.We do plan to share IPD. we will share all IPD that results in a publication on a public repository, as required by most journals. the data will be de-identified and anonymized.

Dose escalation decisions are based on both effectiveness (as assessed by mean worst pain on the NRS) and DLT. The dose escalation population will include all subjects who are dosed, complete the NRS, and have the DLT assessments from baseline through Day 15. Subjects who are not evaluable for dose escalation will be replaced.

The secondary outcome variables will be summarized over time by dose cohort as appropriate for the outcome measure. Absolute and percentage change in the NRS and VAS pain scores between the pre- and post-RTX dosing assessments (baseline period and study Days 8 through 14, respectively) will also be summarized.

National Institute of Neurological Disorders and Stroke (NINDS)

Sorrento Therapeutics, Inc.

National Institute of Dental and Craniofacial Research (NIDCR)

Back Pain

Chronic Pain

Morphine

New candidates who will receive the Prometra Programmable Intrathecal Infusion Pump

Patients who were part of the previous IDE study, still have an active Prometra Programmable Intrathecal Infusion Pump, and are willing to continue in a study protocol.

There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.

Prometra Programmable Intrathecal Infusion Pump

Cory Brantley

The Prometra Pump is approved by the FDA for use in the United States. The purpose of this study is to collect long-term safety data on the Prometra Pump.

This study is proposed under part of the post-Premarket Approval (PMA) requirements. This study is a prospective, non-randomized, open-label, multicenter study. It will be performed at 10-30 centers in the US and enroll a maximum of 400 subjects. Subjects will be followed for a total of five years.

Prometra Post-Approval Study

A Prospective, Non-randomized, Open-label, Multicenter Study to Evaluate the Long-term Safety of the Prometra Programmable Pump System

Tabulation of device-related adverse events

Tabulation of device-related serious adverse events

The effect of race and ethnicity on granuloma formation

The effect of alternative drugs on granuloma formation

The primary hypothesis is that the 5-year rate of patients with granuloma formation will be noninferior to that in the literature. The literature rate was found to be approximately 3% and the noninferiority margin will be three percentage points.

Tabulation of pump failures, including time to occurrence and type

Tabulation of occurences of premature pump battery depletions

Flowonix Medical

Behaviors and Mental Disorders

Quality of Life

Schedule a maximum of 3 periganglionic DRG injection(s) at contiguous level(s) to treat targeted DRG responsible for chronic CIBP

Resiniferatoxin (RTX) is an ultrapotent agonist analog of capsaicin that targets a receptor expressed on specific dorsal root sensory ganglia (DRG) neurons and is expected to reduce pain within the targeted zone.

Resiniferatoxin

Tracy S Williams, R.N.

Background:

Cancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to anxiety, depression, and reduced mobility and quality of life. Researchers believe a research drug called resiniferatoxin (RTX) may be able to help.

Objective:

To learn whether RTX is safe and can reduce cancer induced bone pain.

Eligibility:

People ages 18 and older with CIBP that is not relieved by standard treatments

Design:

Participants will have up to 6 outpatient visits over about 7 months. These will include:

Medical history

Physical exam

Blood and urine tests.

Thermal testing: a disk placed on the skin to test ability to sense temperature in and around the area of pain

Chest x-ray

EKG: stickers are placed on the chest to measure heart signals

ECG: measures electrical activity of the heart

Participants will have 1 inpatient visit lasting 2-4 days. This will include:

Catheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray contrast.

A needle is passed through the skin of the back to inject the RTX.

Participants will keep a log of the pain medications they take after surgery.

Participants will be called 1 week and 2, 3, and 4 months after the injection.

Participants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after the injection.

Cancer-induced bone pain (CIBP) is a common clinical problem. While primary osteosarcoma is relatively uncommon, bone metastases frequently cause cancer-related pain with metastatic spread to bone in 60-84% of cases. Resiniferatoxin (RTX) is an ultrapotent agonist analog of capsaicin that targets a receptor expressed on specific dorsal root sensory ganglia (DRG) neurons and is expected to reduce pain within the targeted zone. The overall program goal is to develop a new treatment for intractable chronic pain below the mid-thoracic level resulting from CIBP that has not been controlled with conservative treatments.

Objectives:

The primary objective it to determine the maximum tolerated dose (MTD) of RTX when injected near one or more DRGs, to characterize its safety/toxicity profile, and to identify any dose-limiting toxicity (DLT). The secondary objectives are to determine the relative change in pain reduction, the change in opioid analgesic consumption and quality of life prior to RTX injection and at the various post RTX timepoints.

Study Population

Up to 30 adult subjects are estimated to be necessary for enrollment to have up to 16 subjects who will receive RTX and provide study-related assessment results through the 30-day time point.

Design

The study is a single center, open-label Phase 1b dose escalation safety and efficacy trial for adult subjects with intractable pain due to CIBP below the mid-thoracic level. Those subjects who meet all inclusion and exclusion criteria will undergo various study procedures and then be scheduled for the unilateral periganglionic (PG) DRG injection(s) (a maximum of 3 contiguous levels) under fluoroscopic guidance to treat the targeted DRGs demonstrated to be responsible for the chronic CIBP. The RTX will be injected at 1 of 4 dose levels, 0.8mcg/DRG, 1.6 mcg/DRG, 3.2 mcg/DRG or 6.4 mcg/DRG. The adaptivedesign algorithm for this study utilizes outcome dependent randomization, a process that selects the dose to be administered to the next subject based on all previous outcomes. In this schema, DLT is the measure that will be used to determine if it is safe to escalate to the next highest dose level.

Subjects who are screen failures and those who prematurely terminate participation will be replaced until 16 subjects have received the injection(s) and completed study-related assessments through the day 30 (D30) timepoint. There is no placebo group because of the invasive nature of the injection and the dose escalation performed in the study.

Outcome Measures

The primary outcome is to achieve a dose-response relationship for safety. All subjects will receive RTX. The secondary outcome measures are: 1) change in NRS and VAS scores at the post-RTX assessments compared to pre RTX assessment, 2) change of opioid usage (in MME) at post RTX assessments compared to pre RTX assessment; 3) comparison SF-36 and BDI at pre RTX injection and Days 14, 37, and 187.

The efficacy outcome variable will be evaluated by establishing dose-response curves, with dose plotted on the x-axis and changes in efficacy endpoints (before RTX treatment and at the post RTX assessment visits) plotted on the y-axis. If, at the end of the study, all dose levels of RTX have equal pain-relieving efficacy, the Data Safety Monitoring Committee (DSMC) may determine if it is appropriate to include a dose lower than 0.8 mcg and/or a control group. On the other hand, if the dose-response curves show that higher doses could result in greater pain-relieving efficacy, the protocol may be amended to include higher doses of RTX.

Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain

An Open-Label, Phase 1b Safety and Efficacy Trial of Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain

The primary study outcome measures are related to safety and toxicity of the investigational agent. The primary study outcome measures are: DLT MTD of RTX

The average of the daily worst NRS scores will be used throughout the study for post-injection visits.

The BPI is a validated tool designed to assess the severity of pain and the impact of pain on daily functions in patients with cancer pain and pain due to other chronic diseases.

Single dose of Resiniferatoxin (25 mcg in 3 mL) injected epidurally

Standard of care treatment as determined by the investigator

Resiniferatoxin is a TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.

Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.

Standard of Care

Monica Luchi, MD

This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.

This study is a multicenter, randomized Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care (SOC) for the treatment of intractable pain associated with cancer. Subjects will be followed for 12 weeks after treatment.

Follow-up visit examinations will be performed by a blinded outcomes assessor.

Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain

A Multicenter, Randomized, 2-Arm, Phase 3 Study to Assess the Efficacy and Safety of a Single Epidural Administration of Resiniferatoxin Versus Standard of Care (SoC) for the Treatment of Intractable Pain Associated With Cancer

Change from baseline to Week 4 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)

Change from baseline to Weeks 8 and 12 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)

AUC calculated on change from baseline through Week 4 in worst pain in the target pain location over the previous 24 hours, using the NPRS (0-10)

Incidence and severity of AEs assessed using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Change in Quality of Life from baseline to week 4 based on total score from the BPI-SF, modified to record the target pain treated with study drug

Duration of response defined as time from ≥20% decrease from baseline in worst pain score in the target pain location to ≥20% increase from the nadir of the worst pain score

Change from baseline to Week 4 in the intensity of average pain over the previous 24 hours in the target pain location as measured by the NPRS (0-10)

Pharmaceutical Solutions

After placement of the implantable pump, continuous flow is scheduled by physician and the patient can't modify it.

After placement of the implantable pump, programmable flow is scheduled by physician and patient can do himself morphine bolus injections for a better control of acute episodes of pain.

Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Continuous morphine's flow is scheduled.

Implantable pump with continuous flow

Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Programmable morphine's flow is scheduled.

Implantable pump with programmable flow.

Denis Dupoiron, MD

The aim of this study is to compare intrathecal morphine administration: using a pump with continuous or programmable flow.

Cancer is frequently associated with pain. In spite of recent improvements in cancer related pain treatment, incidence of cancerous chronic pain did not decrease. Indeed, 15 to 20% of patients are still suffering from intractable pain despite an optimal symptom management.

Treatment of cancer pain is generally based on the WHO analgesic ladder according to 3 steps. Patients with advanced cancer are often treated at WHO step 3 analgesics, i.e. morphine and its derivatives, at high dosages. But increasing the dosage of opioids also leads to accentuation of their adverse events and the corresponding risks.

At this stage of the disease, in patients with failure of conventional analgesic therapy, intrathecal injection of analgesics can be decided in order to relieve pain. 2 types of pumps allow intrathecal morphine administration : continuous or programmable flow. In this study, we want to compare the quality of analgesia obtained through these 2 flows.

Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow

Comparison of Two Types of Intrathecal Morphine Administration by Pump for Analgesia in Cancer Patients With Failure of Conventional Analgesic Therapy.

Pain will be assessed every day by patient using a Visual Analog Scale (VAS. VAS scores will be compared between 2 groups(continuous or programmable flow). We want to demonstrate the superiority of intrathecal analgesia obtained through programmable flow compared to continuous flow.

Using Visual Analog Scale's score, we want to demonstrate the superiority of intrathecal analgesia compared to previous treatment (pain is assessed through VAS within 4 days before inclusion).

We want to demonstrate a reduction of adverse events related to intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.

Adverse events due to morphine (6 types) will be scored according to 4 levels, then the sum of these scores will constitute an adverse event severity index ranging from 0 to 18. This index will be compared between the 2 arms and will also be compared to baseline values before introduction of intrathecal analgesia.

We want to demonstrate improvement of the patient's performance status during intrathecal analgesia compared to the previous treatment and to compare the two delivery systems.

We want to compare the incidence and type of complications (infectious, morphine-related and co-analgesic treatments-related, due to the intrathecal catheter, to the implantable pump) between the two delivery systems.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated	NCT02069067	Advanced Cancer		-	National Cancer Institute, Naples
Safety and Activity Study of Intrathecally Administered Ziconotide for Neuropathic Pain in Patients With Cancer	NCT00996983	Pain Neuropathic Pai... Intractable Pai... Cancer	ziconotide	18 Years -	National Cancer Institute, Naples
NP2 Enkephalin For Treatment of Intractable Cancer Pain	NCT01291901	Intractable Pai... Neoplasms	NP2 Placebo	18 Years -	Diamyd Inc
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer	NCT00804154	Intractable Pai... Palliative Care	Intrathecal Res...	18 Years -	National Institutes of Health Clinical Center (CC)
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
NP2 Enkephalin For Treatment of Intractable Cancer Pain	NCT01291901	Intractable Pai... Neoplasms	NP2 Placebo	18 Years -	Diamyd Inc
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain	NCT02522611	Intractable Pai... Palliative Care	Resiniferatoxin	18 Years - 150 Years	National Institutes of Health Clinical Center (CC)
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated	NCT02069067	Advanced Cancer		-	National Cancer Institute, Naples
NP2 Enkephalin For Treatment of Intractable Cancer Pain	NCT01291901	Intractable Pai... Neoplasms	NP2 Placebo	18 Years -	Diamyd Inc
Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain	NCT02522611	Intractable Pai... Palliative Care	Resiniferatoxin	18 Years - 150 Years	National Institutes of Health Clinical Center (CC)
Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain	NCT04572776	Pain, Intractab... Pain Cancer	Resiniferatoxin Standard of Car...	18 Years -	Sorrento Therapeutics, Inc.
Prometra Post-Approval Study	NCT01854229	Chronic Pain Cancer Pain Intractable Pai... Back Pain	Prometra Progra...	22 Years -	Flowonix Medical
Intrathecal Morphine Administration Using Implantable Pump With Continuous or Programmable Flow	NCT01567345	Advanced Cancer Intractable Pai...	Implantable pum... Implantable pum...	18 Years -	Institut Cancerologie de l'Ouest

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