Trial Outcomes & Findings for Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain (NCT NCT03761277)
NCT ID: NCT03761277
Last Updated: 2023-02-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
Baseline to 6-Month Visit
Results posted on
2023-02-08
Participant Flow
Subjects were enrolled from 2019 through 2021 at 16 sites.
Subjects are considered enrolled at the time the informed consent form is signed. At the Baseline Visit, consented subjects are assessed for eligibility to the study-specific inclusion and exclusion criteria. Subjects who meet all eligibility criteria begin the systemic opioid weaning process prior to initiating the intrathecal drug trial. Subjects with a successful intrathecal trial are eligible for an Intrathecal Drug Delivery System Implant. Non-implanted subjects are exited from the study.
Participant milestones
| Measure |
Enrolled Subjects
All consented subjects are considered enrolled in the study. Enrolled subjects do not receive a treatment intervention before Intrathecal Trial. Subjects who met eligibility criteria proceeded to the Intrathecal Trial procedure. The intrathecal drug trial was conducted according to the investigator's standard of care procedures. A successful intrathecal trial was determined by the investigator.
Subjects with a successful intrathecal trial were eligible for implant of the Intrathecal Drug Delivery System (IDDS).
Subjects who were implanted with the IDDS were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with utilization of the lowest reasonable daily dose of IT PFMS.
|
|---|---|
|
Enrollment to Implant
STARTED
|
93
|
|
Enrollment to Implant
Intrathecal Trial
|
72
|
|
Enrollment to Implant
COMPLETED
|
52
|
|
Enrollment to Implant
NOT COMPLETED
|
41
|
|
Post-Implant to 6 Months
STARTED
|
52
|
|
Post-Implant to 6 Months
COMPLETED
|
47
|
|
Post-Implant to 6 Months
NOT COMPLETED
|
5
|
|
6 Months to 12 Months
STARTED
|
47
|
|
6 Months to 12 Months
COMPLETED
|
19
|
|
6 Months to 12 Months
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Enrolled Subjects
All consented subjects are considered enrolled in the study. Enrolled subjects do not receive a treatment intervention before Intrathecal Trial. Subjects who met eligibility criteria proceeded to the Intrathecal Trial procedure. The intrathecal drug trial was conducted according to the investigator's standard of care procedures. A successful intrathecal trial was determined by the investigator.
Subjects with a successful intrathecal trial were eligible for implant of the Intrathecal Drug Delivery System (IDDS).
Subjects who were implanted with the IDDS were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with utilization of the lowest reasonable daily dose of IT PFMS.
|
|---|---|
|
Enrollment to Implant
Screen Failure
|
17
|
|
Enrollment to Implant
Withdrawal by Subject
|
17
|
|
Enrollment to Implant
Physician Decision
|
2
|
|
Enrollment to Implant
Site Closure
|
3
|
|
Enrollment to Implant
Sponsor Request
|
2
|
|
Post-Implant to 6 Months
Adverse Event
|
2
|
|
Post-Implant to 6 Months
Death
|
1
|
|
Post-Implant to 6 Months
Site Closure
|
2
|
|
6 Months to 12 Months
Completed Study under Protocol v3
|
25
|
|
6 Months to 12 Months
Physician Decision
|
2
|
|
6 Months to 12 Months
Withdrawal by Subject
|
1
|
Baseline Characteristics
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain
Baseline characteristics by cohort
| Measure |
Targeted Drug Delivery Subjects
n=52 Participants
All subjects implanted with the Intrathecal Drug Delivery System (IDDS). Subjects were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS. The following IT PFMS dose initiation parameters were recommended: (1) A starting PFMS dose of 0.1 to 0.5 mg/day, or half the effective trial dose, with lower initial PFMS doses considered, and (2) a starting concentration to achieve an estimated pump refill interval of 120 days, but not to exceed 180 days. IT PFMS dose increases or decreases could be made any time throughout the duration of study.
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|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
|
Pain (Visual Analog Scale, VAS, 0-100)
|
75.5 units on a scale
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Numerical Opioid Side Effect Assessment (NOSE, 0-100)
|
21.3 units on a scale
STANDARD_DEVIATION 20.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6-Month VisitPopulation: A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant.
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.
Outcome measures
| Measure |
Targeted Drug Delivery Subjects
n=42 Participants
All subjects implanted with the Intrathecal Drug Delivery System (IDDS). Subjects were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS.
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|---|---|
|
Number of Participants With Clinical Success at the 6-Month Visit
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6-Month VisitPopulation: A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant.
To demonstrate pain intensity scores (Visual Analog Scale, VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, with a non-inferiority margin of 10mm. Pain was assessed using a Visual Analog Scale, ranging from 0-100, where 0 is no pain and 100 is the worst pain. 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 made a perpendicular mark on the VAS line that best describes their average pain in the last 24 hours. Change in VAS is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in pain intensity.
Outcome measures
| Measure |
Targeted Drug Delivery Subjects
n=42 Participants
All subjects implanted with the Intrathecal Drug Delivery System (IDDS). Subjects were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS.
|
|---|---|
|
Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit
|
-15 units on a scale
Interval -22.7 to -7.1
|
SECONDARY outcome
Timeframe: Baseline to 6-Month VisitPopulation: A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant.
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, where 0 is no opioid-related side effects and 100 is the worst opioid-related side effects. Change in NOSE is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in opioid-related side effects.
Outcome measures
| Measure |
Targeted Drug Delivery Subjects
n=42 Participants
All subjects implanted with the Intrathecal Drug Delivery System (IDDS). Subjects were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS.
|
|---|---|
|
Numerical Opioid Side Effect (NOSE) Assessment Tool
|
-9.4 score on a scale
Interval -15.4 to -3.4
|
SECONDARY outcome
Timeframe: Baseline to 6-Month VisitPopulation: The subset of Targeted Drug Delivery Subjects who have a drug test at the 6-Month Visit and no more than 1 missing drug test through the 6-Month Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, 42 maintained ITMM through the 6M Visit, and 41 completed a drug test at the 6-Month and had no more than 1 missing drug test through the 6-Month Visit.
To characterize the number of subjects who eliminate systemic opioids through the 6-Month Visit. Four drug tests for systemic opioid use are administered from intrathecal therapy initiation through the 6-Month Visit. If all of the available drug tests are negative for systemic opioid use, the subject is counted as eliminating systemic opioids through the 6-Month Visit. The number of subjects who eliminated systemic opioids through the 6-Month Visit is presented.
Outcome measures
| Measure |
Targeted Drug Delivery Subjects
n=41 Participants
All subjects implanted with the Intrathecal Drug Delivery System (IDDS). Subjects were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS.
|
|---|---|
|
Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit
|
31 Participants
|
Adverse Events
Enrolled Subjects
Serious events: 20 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Enrolled Subjects
n=93 participants at risk
All consented subjects are considered enrolled in the study. Enrolled subjects do not receive a treatment intervention before Intrathecal Trial. Subjects who met eligibility criteria proceeded to the Intrathecal Trial procedure. The intrathecal drug trial was conducted according to the investigator's standard of care procedures. A successful intrathecal trial was determined by the investigator.
Subjects with a successful intrathecal trial were eligible for implant of the Intrathecal Drug Delivery System (IDDS).
Subjects who were implanted with the IDDS were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS.
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Ear and labyrinth disorders
Vertigo
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
General disorders
Drug withdrawal syndrome
|
2.2%
2/93 • Number of events 2 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
Sepsis
|
2.2%
2/93 • Number of events 2 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
COVID-19
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
Implant site infection
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
Intervertebral discitis
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
Pneumonia
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Infections and infestations
Wound infection pseudomonas
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Investigations
Blood glucose increased
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.2%
2/93 • Number of events 2 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Psychiatric disorders
Mental status changes
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
2/93 • Number of events 2 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.2%
2/93 • Number of events 3 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.2%
2/93 • Number of events 2 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/93 • Number of events 1 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
|
Other adverse events
| Measure |
Enrolled Subjects
n=93 participants at risk
All consented subjects are considered enrolled in the study. Enrolled subjects do not receive a treatment intervention before Intrathecal Trial. Subjects who met eligibility criteria proceeded to the Intrathecal Trial procedure. The intrathecal drug trial was conducted according to the investigator's standard of care procedures. A successful intrathecal trial was determined by the investigator.
Subjects with a successful intrathecal trial were eligible for implant of the Intrathecal Drug Delivery System (IDDS).
Subjects who were implanted with the IDDS were treated via the IDDS with intrathecal preservative-free morphine sulfate (IT PFMS), at a concentration not exceeding 25 mg/mL and 0.9% solution of preservative-free sodium chloride injection (USP) for dilution. IT PFMS initiation and subsequent dosing adjustments were determined based on specific patient needs and clinician standard practices, with the goal to maintain or improve pain control and/or opioid-related side effects (compared to Baseline) with utilization of the lowest reasonable daily dose of IT PFMS.
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Renal and urinary disorders
Urinary retention
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7.5%
7/93 • Number of events 9 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
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General disorders
Adverse drug reaction
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9.7%
9/93 • Number of events 14 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
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General disorders
Drug withdrawal syndrome
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5.4%
5/93 • Number of events 5 • Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.
Any adverse event (AE) meeting the definition of systemic opioid weaning-related, device-related, intrathecal drug-related, and procedure-related, all serious adverse events and deaths (regardless of relatedness) for all subjects from consent to the 12-Month Visit, were collected. Subjects were assessed for adverse events by the investigator at each scheduled and unscheduled study visit.
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Additional Information
Pain Therapies Clinical Research Director
Medtronic Neuromodulation Clinical Research
Phone: 763-514-4000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee No manuscripts, abstracts, or case reports that jeopardize the primary publication will be submitted prior to the submission of the primary publication. It is required that all publications undergo review at Medtronic for confidential information and technical accuracy prior to publication.
- Publication restrictions are in place
Restriction type: OTHER