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

Sponsor

MedtronicNeuro (Industry)

Overall Status

Completed

CT.gov ID

NCT03761277

Collaborator

(none)

Enrollment

Locations

Arm

34.7

Actual Duration (Months)

5.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

N/A

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 :

Jan 16, 2019

Actual Primary Completion Date :

Dec 6, 2021

Actual Study Completion Date :

Dec 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).

Arm

Intervention/Treatment

Other: 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).

Outcome Measures

Primary Outcome Measures

Clinical Success at the 6-Month Visit [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

Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit [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.
Numerical Opioid Side Effect (NOSE) Assessment Tool [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.
Systemic Opioid Elimination [Baseline to 6-Month Visit]
To characterize the proportion of subjects who eliminate systemic opioids through the 6-Month Visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neuroversion	Anchorage	Alaska	United States	99508
2	Coastal Pain and Spinal Diagnostics	Carlsbad	California	United States	92009
3	Napa Valley Orthopaedic Medical Group	Napa	California	United States	94558
4	Florida Pain Institute	Merritt Island	Florida	United States	32935
5	Regional Brain & Spine, LLC	Cape Girardeau	Missouri	United States	63701
6	Christian Hospital Pain Management	Saint Louis	Missouri	United States	63136
7	Comprehensive and Interventional Pain Management	Henderson	Nevada	United States	89052
8	The Pain Management Center	Voorhees	New Jersey	United States	08043
9	Premier Pain Treatment Institute	Mount Orab	Ohio	United States	45154
10	Clinical Investigations, LLC	Edmond	Oklahoma	United States	73013
11	Moss Rehabilitation-Einstein Healthcare Network	Elkins Park	Pennsylvania	United States	19027
12	University of Texas Medical Branch	Galveston	Texas	United States	77555
13	Precision Spine Care	Tyler	Texas	United States	75701
14	University of Virginia Pain Management Center	Charlottesville	Virginia	United States	22908
15	Eastern Virginia Medical School	Norfolk	Virginia	United States	23507
16	Northwest Pain Care, Inc.	Spokane	Washington	United States	99201