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

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ClinicalTrials.gov Identifier: NCT03761277
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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.

Condition or disease Intervention/treatment Phase
Chronic Non-malignant Pain Chronic Pain Pain, Back Pain, Leg Device: Medtronic SynchroMed™ II infusion system Drug: Preservative-free morphine sulfate (PFMS) Phase 4

Detailed Description:
Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intrathecal Therapy
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
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™).

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




Primary Outcome Measures :
  1. Clinical Success at the 6-Month Visit [ Time Frame: Baseline to 6-Month Visit ]
    To characterize the proportion 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 with equal pain 2) Reduced pain with equal opioid-related side effects 3) Reduced pain and reduced opioid-related side effects.


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit [ Time Frame: Baseline to 6-Month Visit ]
    To demonstrate pain intensity scores (VAS) at the 6-Month Visit is non-inferior to VAS at Baseline. Pain will be assessed using VAS. The VAS is a 100mm line, with "No pain" on the left side of the line and "Worst pain imaginable" on the right side of the line. Subjects will be asked to make a perpendicular mark on the VAS line that best describes their average pain in the last 24 hours.

  2. Numerical Opioid Side Effect (NOSE) Assessment Tool [ Time Frame: Baseline to 6-Month Visit ]
    To characterize the change in opioid-related side effects scores (NOSE) from Baseline to the 6-Month Visit. The Numerical Opioid Side Effect (NOSE) Assessment Tool is a tool to evaluate 10 opioid-related side effects using a 11-point numerical scale. Subjects are asked to evaluate each of the 10 opioid-related side effects on a scale of 0 - 10 with 0 being "not present" and 10 being "as bad as you can imagine". A total sum score can range from 0 - 100.

  3. Systemic Opioid Elimination [ Time Frame: Baseline to 6-Month Visit ]
    To characterize the proportion of subjects who eliminate systemic opioids through the 6-Month Visit.



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

Inclusion Criteria:

  1. 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
  2. A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
  3. A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
  4. Current daily systemic opioid dose of >0 and ≤ 120 Morphine Milligram Equivalents (MME)
  5. 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
  6. Psychological evaluation or investigator assessment of patient psychological suitability for study participation
  7. Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
  8. At least 18 years old at time of enrollment
  9. Willing and able to attend visits and comply with the study protocol
  10. 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

Exclusion Criteria:

  1. Previously trialed or implanted with an IDDS
  2. Concomitant stimulation device implanted for the treatment of pain
  3. 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.)
  4. 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
  5. Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
  6. Currently using cannabinoids or illicit drugs
  7. History of allergy or significant adverse reaction to morphine per investigator discretion
  8. Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team

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): NCT03761277


Contacts
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Contact: Embrace TDD Study Team 1-763-514-4000 rs.embracetdd@medtronic.com

Locations
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United States, California
Coastal Pain and Spinal Diagnostics Recruiting
Carlsbad, California, United States, 92009
United States, Florida
Florida Pain Institute Recruiting
Merritt Island, Florida, United States, 32935
United States, Missouri
Regional Brain & Spine, LLC Recruiting
Cape Girardeau, Missouri, United States, 63701
Christian Hospital Pain Management Recruiting
Saint Louis, Missouri, United States, 63136
United States, Nevada
Comprehensive and Interventional Pain Management Recruiting
Henderson, Nevada, United States, 89052
United States, New Jersey
The Pain Management Center Recruiting
Voorhees, New Jersey, United States, 08043
United States, Ohio
Premier Pain Treatment Institute Recruiting
Mount Orab, Ohio, United States, 45154
United States, Oklahoma
Clinical Investigations, LLC Recruiting
Edmond, Oklahoma, United States, 73013
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Moss Rehabilitation-Einstein Healthcare Network Recruiting
Elkins Park, Pennsylvania, United States, 19027
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
United States, Virginia
University of Virginia Pain Management Center Recruiting
Charlottesville, Virginia, United States, 22908
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23507
United States, Washington
Northwest Pain Care, Inc. Recruiting
Spokane, Washington, United States, 99201
Sponsors and Collaborators
MedtronicNeuro

Additional Information:
Publications:

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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03761277     History of Changes
Other Study ID Numbers: MDT18026
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by MedtronicNeuro:
Pain
Intrathecal
Targeted Drug Delivery (TDD)
Non-Malignant Pain
Systemic Opioids
Opioid Weaning
Pain Pump
Drug Pump
Medtronic Pump
Additional relevant MeSH terms:
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Chronic Pain
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Morphine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents