Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain

NCT03761277 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: MDT18026
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 16

Brief Summary

This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.

Conditions

Chronic Non-malignant Pain; Chronic Pain; Pain, Back; Pain, Leg

Keywords

Pain; Intrathecal; Targeted Drug Delivery (TDD); Non-Malignant Pain; Systemic Opioids; Opioid Weaning; Pain Pump; Drug Pump; Medtronic Pump

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Success at the 6-Month Visit

  To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented.

  Baseline to 6-Month Visit

Secondary Outcomes (3)

• Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit

  Baseline to 6-Month Visit

• Numerical Opioid Side Effect (NOSE) Assessment Tool

  Baseline to 6-Month Visit

• Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit

  Baseline to 6-Month Visit

Study Arms (1)

Intrathecal Therapy

OTHER

Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS).

Device: Medtronic SynchroMed™ II infusion system; Drug: Preservative-free morphine sulfate (PFMS)

Interventions

Medtronic SynchroMed™ II infusion system DEVICE

Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).

Intrathecal Therapy

Preservative-free morphine sulfate (PFMS) DRUG

The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).

Intrathecal Therapy

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
• A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
• A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
• Current daily systemic opioid dose of \>0 and ≤ 120 Morphine Milligram Equivalents (MME)
• A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit
• Psychological evaluation or investigator assessment of patient psychological suitability for study participation
• Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
• At least 18 years old at time of enrollment
• Willing and able to attend visits and comply with the study protocol
• Male or non-pregnant, non-lactating female. Females must be post-menopausal or surgically sterile; or be utilizing a medically acceptable form of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide) for the duration of the study

You may not qualify if:

• Previously trialed or implanted with an IDDS
• Concomitant stimulation device implanted for the treatment of pain
• Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
• Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
• Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
• Currently using cannabinoids or illicit drugs
• History of allergy or significant adverse reaction to morphine per investigator discretion
• Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (16)

Neuroversion

Anchorage, Alaska, 99508, United States

Location

Coastal Pain and Spinal Diagnostics

Carlsbad, California, 92009, United States

Location

Napa Valley Orthopaedic Medical Group

Napa, California, 94558, United States

Location

Florida Pain Institute

Merritt Island, Florida, 32935, United States

Location

Regional Brain & Spine, LLC

Cape Girardeau, Missouri, 63701, United States

Location

Christian Hospital Pain Management

St Louis, Missouri, 63136, United States

Location

Comprehensive and Interventional Pain Management

Henderson, Nevada, 89052, United States

Location

The Pain Management Center

Voorhees Township, New Jersey, 08043, United States

Location

Premier Pain Treatment Institute

Mount Orab, Ohio, 45154, United States

Location

Clinical Investigations, LLC

Edmond, Oklahoma, 73013, United States

Location

Moss Rehabilitation-Einstein Healthcare Network

Elkins Park, Pennsylvania, 19027, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

University of Virginia Pain Management Center

Charlottesville, Virginia, 22908, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Northwest Pain Care, Inc.

Spokane, Washington, 99201, United States

Location

Related Publications (6)

• Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE; Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002 Oct 1;20(19):4040-9. doi: 10.1200/JCO.2002.02.118.

  PMID: 12351602 BACKGROUND

• Hamza M, Doleys D, Wells M, Weisbein J, Hoff J, Martin M, Soteropoulos C, Barreto J, Deschner S, Ketchum J. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.

  PMID: 22845187 BACKGROUND

• Grider JS, Etscheidt MA, Harned ME, Lee J, Smith B, Lamar C, Bux A. Trialing and Maintenance Dosing Using a Low-Dose Intrathecal Opioid Method for Chronic Nonmalignant Pain: A Prospective 36-Month Study. Neuromodulation. 2016 Feb;19(2):206-19. doi: 10.1111/ner.12352. Epub 2015 Oct 19.

  PMID: 26477685 BACKGROUND

• Hamza M, Doleys DM, Saleh IA, Medvedovsky A, Verdolin MH, Hamza M. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain. Neuromodulation. 2015 Oct;18(7):636-48; discussion 649. doi: 10.1111/ner.12342. Epub 2015 Aug 26.

  PMID: 26307558 BACKGROUND

• Wilkes DM, Orillosa SJ, Hustak EC, Williams CG, Doulatram GR, Solanki DR, Garcia EA, Huang LM. Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics. Pain Med. 2018 Sep 1;19(9):1782-1789. doi: 10.1093/pm/pnx132.

  PMID: 29016893 BACKGROUND

• Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug;14(4):343-51.

  PMID: 21785477 BACKGROUND

Related Links

• Applicable Product Manual(s) for the SynchroMed II infusion system

MeSH Terms

Conditions

Chronic Pain; Back Pain; Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Protocol V3.0 revised the last study visit from the 12-Month Visit to the 6-Month Visit at a point in the study where some subjects, but not all, had already progressed beyond the 6-Month Visit. Thus, subjects consented under Protocol V3.0 may complete the study without completing the 12-Month Visit. This protocol revision did not impact the Primary and Secondary endpoints, which are evaluated at 6 months.

Results Point of Contact

• Title: Pain Therapies Clinical Research Director
• Organization: Medtronic Neuromodulation Clinical Research

rs.embracetdd@medtronic.com

763-514-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: December 3, 2018
• Study Start: January 16, 2019
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: February 8, 2023
• Results First Posted: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)