Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population

NCT04096391 | Completed DMC FDA Device

• 1 other identifier: Prosper-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.

Conditions

Chronic Nonmalignant Pain; Pain, Intractable; Pain, Chronic

Keywords

Truncal Pain; Lower Extremity Limb Pain; Refractory Pain

Outcome Measures

Primary Outcomes (1)

• Compare the change in Numeric Pain Rating Scale between the IDDS group and the CMM group

  The Numeric Pain Rating Scale (NPRS) is a 0-10 numeric pain rating scale (11 point scale), where a higher scores equates to more pain. The primary endpoint for this post-marketing study is the comparison of the NPRS between the IDDS group and the CMM group collected in the Study Diary at various time points.

  Comparisons will be done prior to baseline visit and at 3, 6, 9 and 12 month visits.

Secondary Outcomes (3)

• Compare the change in PROMIS 29 scores between the IDDS group and CMM group

  Individual subject scores recorded at baseline visit and at 3, 6, 9 and 12 month visits.

• Comparison of the accrued cost of therapy for pain

  Cost of therapy will be obtained at 3, 6, 9 and 12 month visits.

• Comparison of other concurrent treatments

  Individual subject counts recorded at 3, 6, 9 and 12 month visits will be compared.

Study Arms (2)

Intrathecal Drug Delivery System

ACTIVE COMPARATOR

Subjects randomized to the Intrathecal Drug Delivery System group will be implanted with the Prometra System under sterile technique in accordance with the Instructions for Use. The pump will be filled at the time of implantation with the prescribed medication.

Device: Flowonix Prometra® II Programmable Infusion System

Conventional Medical Management

ACTIVE COMPARATOR

Subjects randomized to the Conventional Medical Management group will continue with the standard of care procedures.

Drug: Pain Medicine

Interventions

Flowonix Prometra® II Programmable Infusion System DEVICE

The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).

Intrathecal Drug Delivery System

Pain Medicine DRUG

Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Also known as: Systemic opioid therapy

Conventional Medical Management

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have signed and dated the IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed
• Subject must be willing and able to complete study requirements including diaries, questionnaires and attend all visits, in the opinion of the investigator
• Subject must be male or female and at least 22 years of age
• Subjects who are female are non-lactating and if of childbearing potential have a negative urine pregnancy test at screening
• Subjects who are currently be receiving ≤ 90 mg/day morphine per day dose (or MME), with stable dose at equivalent of systemic opioids at Screening
• Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening as documented in medical history;
• Subjects who have refractory pain despite failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments, etc.
• Subjects who are a new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)
• Subjects have not been implanted with a spinal cord stimulator for pain
• Subjects currently do not have an implanted spinal cord stimulator for pain
• Subjects who have a diagnosis of nonmalignant, chronic intractable pain as documented in the medical history
• Subjects who are medically stable and able to undergo surgery for implantation of the Prometra® II Infusion System
• Subject must have completed a psychological evaluation within 6 months prior to Screening
• Subject must complete an intrathecal trial resulting in candidacy for pump implantation during Screening

You may not qualify if:

• A potential subject who has any contraindications listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study:
• Subjects currently have a spinal cord stimulator implanted for pain
• Subjects previously had a spinal cord stimulator implanted for pain
• Subjects who have psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion
• Subjects who have a history of alcohol abuse or illicit drug use within 2 years of screening
• Subjects who have an active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to Screening
• Subjects who are female and who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a form of contraception during the study.
• Subjects who plan to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening
• Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
• At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:
• Subjects that have a mean of the reported 12 hour "average" NPRS responses of \< 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit (as recorded in the electronic Study Diary) in the absence of intolerable side effects as documented in the medical history
• Subjects with a negative urine test for opioids at Baseline
• Subjects with a positive Pregnancy test, if applicable
• Subjects that failed the intrathecal trial during Screening

Sponsors & Collaborators

• Evolve Restorative Center: lead
• Flowonix Medical: collaborator
• Celéri Health, Inc.: collaborator
• Advanced Infusion Solutions: collaborator

Study Sites (1)

Evolve Restorative Center

Santa Rosa, California, 95403, United States

Location

Related Publications (3)

• Deer TR, Pope JE, Hayek SM, Lamer TJ, Veizi IE, Erdek M, Wallace MS, Grider JS, Levy RM, Prager J, Rosen SM, Saulino M, Yaksh TL, De Andres JA, Abejon Gonzalez D, Vesper J, Schu S, Simpson B, Mekhail N. The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks. Neuromodulation. 2017 Feb;20(2):155-176. doi: 10.1111/ner.12579. Epub 2017 Jan 2.

  PMID: 28042914 BACKGROUND

• Deer TR, Hayek SM, Pope JE, Lamer TJ, Hamza M, Grider JS, Rosen SM, Narouze S, Perruchoud C, Thomson S, Russo M, Grigsby E, Doleys DM, Jacobs MS, Saulino M, Christo P, Kim P, Huntoon EM, Krames E, Mekhail N. The Polyanalgesic Consensus Conference (PACC): Recommendations for Trialing of Intrathecal Drug Delivery Infusion Therapy. Neuromodulation. 2017 Feb;20(2):133-154. doi: 10.1111/ner.12543. Epub 2017 Jan 2.

  PMID: 28042906 BACKGROUND

• Deer TR, Pope JE, Hayek SM, Bux A, Buchser E, Eldabe S, De Andres JA, Erdek M, Patin D, Grider JS, Doleys DM, Jacobs MS, Yaksh TL, Poree L, Wallace MS, Prager J, Rauck R, DeLeon O, Diwan S, Falowski SM, Gazelka HM, Kim P, Leong M, Levy RM, McDowell G II, McRoberts P, Naidu R, Narouze S, Perruchoud C, Rosen SM, Rosenberg WS, Saulino M, Staats P, Stearns LJ, Willis D, Krames E, Huntoon M, Mekhail N. The Polyanalgesic Consensus Conference (PACC): Recommendations on Intrathecal Drug Infusion Systems Best Practices and Guidelines. Neuromodulation. 2017 Feb;20(2):96-132. doi: 10.1111/ner.12538. Epub 2017 Jan 2.

  PMID: 28042904 BACKGROUND

MeSH Terms

Conditions

Pain, Intractable; Chronic Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jason E Pope, MD

  Evolve Restorative Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in a 1:1 ratio to one of two groups

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 19, 2019
• Study Start: June 5, 2019
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)