Chronic Nonmalignant PainProsper-001NCT04096391

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

A study testing Flowonix Prometra® II Programmable Infusion System and Pain Medicine in people with Chronic Nonmalignant Pain and Pain, Intractable, run by Evolve Restorative Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Chronic Nonmalignant Pain, Pain, Intractable, Pain, Chronic
What is being tested?: Flowonix Prometra® II Programmable Infusion System and Pain Medicine
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteUnited States
Study dates: 5 Jun 2019to 11 Apr 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Evolve Restorative Center
Santa Rosa, California, 95403

Other trials in United States

About this study

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

Read the detailed description

This study will evaluate the following objectives:

Primary objective:

To compare the change in pain intensity from baseline based on the Numeric Rating Scale [NRS] between subjects randomized to the IDDS group and subjects randomized to the CMM group.The comparison will be conducted at 3, 6, 9 and 12 months following enrollment. The evaluation at 6 months will be considered the primary time point for evaluation.

Secondary objectives:

For each of the following secondary objectives, the comparisons between the IDDS group and CMM group will be made using the intra-subject change from baseline as the dependent variable.

Compare the subject reported PROMIS 29 between the IDDS group and CMM group. Individual subject scores recorded at baseline and months 3, 6, 9 and 12.
Compare the accrued cost of therapy for pain control including those related to adverse events, ED visits, cost of medications between the IDDS group and CMM group
Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group. Individual subject counts recorded at months 3, 6, 9 and 12 will be compared.

Additional safety objective:

To characterize pain and device related adverse events for all subjects throughout the study through completion of 12 month follow-up or subject exit.

Conditions: Chronic Nonmalignant Pain, Pain, Intractable, Pain, Chronic
Being tested: Flowonix Prometra® II Programmable Infusion System, Pain Medicine
Keywords: Truncal Pain, Lower Extremity Limb Pain, Refractory Pain
Medical subject headings: Pain, Intractable, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Flowonix Prometra® II Programmable Infusion SystemDevice
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).
Pain MedicineDrug
Also called Systemic opioid therapy
Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.

Study groups in NCT04096391
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Pain Medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Compare the subject reported Patient-Reported Outcomes Measurement Information System (PROMIS) 29 between the IDDS group and CMM group. PROMIS 29 assesses pain intensity using a 0-10 numeric rating scale (11 point scale), where a higher score equates to more pain. Other health domains are scored using a Likert scale, where higher scores represent more of the specific domain being measured. The other health domains that are scored are: depression; anxiety; physical function; pain interference; fatigue; sleep disturbance; and ability to participate in social roles and activities.
Measured: 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
Compare the accrued cost of therapy for pain control including those related to adverse events, ED visits, cost of medications between the IDDS group and CMM group.
Measured: Cost of therapy will be obtained at 3, 6, 9 and 12 month visits.
Comparison of other concurrent treatments
Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group.
Measured: Individual subject counts recorded at 3, 6, 9 and 12 month visits will be compared.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 201911 Apr 2022

First posted19 Sep 2019
Study start5 Jun 2019
Primary completion11 Apr 2022
Study completion11 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Nonmalignant PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized in a 1:1 ratio to one of two groups
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04096391
Sponsor's protocol ID: Prosper-001
Acronym: Prosper-001
Status last verified: May 2022
First submitted: 12 Sep 2019
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 28042914
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.
PubMed 28042906
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.
PubMed 28042904

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population (PROSPER)
ClinicalTrials.gov ID: NCT04096391
Acronym / sponsor ID: Prosper-001 / Prosper-001
Conditions: Chronic Nonmalignant Pain, Pain, Intractable, Pain, Chronic
Keywords: Truncal Pain, Lower Extremity Limb Pain, Refractory Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Evolve Restorative CenterUniversity, hospital or other
Collaborators: Flowonix Medical, Celéri Health, Inc., Advanced Infusion Solutions
Study start: 5 Jun 2019 (actual)
Primary completion: 11 Apr 2022 (actual)
Study completion: 11 Apr 2022 (actual)
First posted: 19 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will evaluate the following objectives:

Primary objective:

To compare the change in pain intensity from baseline based on the Numeric Rating Scale [NRS] between subjects randomized to the IDDS group and subjects randomized to the CMM group.The comparison will be conducted at 3, 6, 9 and 12 months following enrollment. The evaluation at 6 months will be considered the primary time point for evaluation.

Secondary objectives:

For each of the following secondary objectives, the comparisons between the IDDS group and CMM group will be made using the intra-subject change from baseline as the dependent variable.

Compare the subject reported PROMIS 29 between the IDDS group and CMM group. Individual subject scores recorded at baseline and months 3, 6, 9 and 12.
Compare the accrued cost of therapy for pain control including those related to adverse events, ED visits, cost of medications between the IDDS group and CMM group
Compare the number of other concurrent treatments performed on each subject between the IDDS group and CMM group. Individual subject counts recorded at months 3, 6, 9 and 12 will be compared.

Additional safety objective:

To characterize pain and device related adverse events for all subjects throughout the study through completion of 12 month follow-up or subject exit.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Subjects will be randomized in a 1:1 ratio to one of two groups

Arm	Type	Receives
Intrathecal Drug Delivery System	Active comparator	Device: Flowonix Prometra® II Programmable Infusion SystemSubjects 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.
Conventional Medical Management	Active comparator	Drug: Pain MedicineSubjects randomized to the Conventional Medical Management group will continue with the standard of care procedures.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flowonix Prometra® II Programmable Infusion SystemThe 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).	Device	Intrathecal Drug Delivery System
Pain MedicineAlso: Systemic opioid therapyInjections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.	Drug	Conventional Medical Management

Primary outcome

Compare the change in Numeric Pain Rating Scale between the IDDS group and the CMM group
Time frame: Comparisons will be done prior to baseline visit and at 3, 6, 9 and 12 month visits.
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.

3 secondary outcomes

Compare the change in PROMIS 29 scores between the IDDS group and CMM group
Time frame: 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
Time frame: Cost of therapy will be obtained at 3, 6, 9 and 12 month visits.
Comparison of other concurrent treatments
Time frame: Individual subject counts recorded at 3, 6, 9 and 12 month visits will be compared.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Background: PubMed 28042914Deer 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.
Background: PubMed 28042906Deer 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.
Background: PubMed 28042904Deer 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason E Pope, MD principal investigator

Evolve Restorative Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the change in Numeric Pain Rating Scale between the IDDS group and the CMM group (time frame: Comparisons will be done prior to baseline visit and at 3, 6, 9 and 12 month visits.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04096391, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 28 Oct 2026.