SpasticityPhase 3CIBINCT01051128
Continuous Intrathecal Baclofen Infusion for Chronic Spasticity
A Phase 3 study testing Prometra Programmable Implantable Pump System in people with Spasticity, run by Flowonix Medical.
Trial summary
The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- Prometra Programmable Implantable Pump System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2010
- Phase
- Phase 3
- 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
- The overall goal of this study is to choose patients most likely to experience therapeutic success while reducing the likelihood of risks, complications and adverse events.
- Patients meeting all of the following criteria will be eligible for enrollment in the study:
- Patient with a history of severe chronic spastic hypertonia in the lower extremities lasting at least 6 months who:
- fail to respond to maximum recommended doses of antispasmodic medications including baclofen, or
- those who experience intolerable CNS side effects at effective oral doses
- Patient is >21 years of age
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- Patient, or legally authorized representative (LAR), has provided written informed consent to participate in the study
- Investigator considers the patient willing and able to fulfill all study requirements
- Investigator has documented attempts to eliminate factors that can contribute to an increase in spasticity (e.g. infection)
- Patient has had a successful trial of Lioresal® for the management of the target spasticity.
Who cannot join
- Patients meeting any of the following criteria are to be excluded from the study:
- Patient has MRI of the spine documenting structural abnormality preventing adequate CSF flow. (If the patient has a medical condition that contraindicates screening MRI, the investigator should proceed with the closest appropriate study i.e. CT scan, X-ray, to rule out any spinal abnormalities that would prevent intrathecal drug administration.)
- Patient's anatomy is not large enough to accommodate the pump's size and weight.
- Patient has a systemic infection.
- Patient has renal insufficiency as evidenced by a baseline serum creatinine of >2.0 mg/dl.
- Patient has a history of a bleeding disorder.
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- Patient has a history of blood clots such as deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year of enrollment.
- Patient is pregnant or breast-feeding, or is of child-bearing potential and not employing effective birth control.
- Patient has known allergies or sensitivities to pump system materials (e.g., silicone rubber, titanium, polyphenylsulfone, acetal resin, polyvinylidene fluoride, tungsten).
- Patient has known allergies to Lioresal® (baclofen), or would be contraindicated for Lioresal® based on the drug labeling.
- Patient has other implantable electronic cardiac devices (i.e. pacemaker, defibrillator, CRT system)
- Patient has an occupation where he/she would be exposed to high current industrial equipment, powerful magnets or transmitting towers, such as, electricians, electrical engineers or MRI technicians.
- Patient is participating in another clinical trial.
About this study
Official title: Continuous Intrathecal Baclofen Infusion for the Management of Chronic Spasticity
The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.
Read the detailed description
The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. Lioresal Intrathecal (baclofen) is indicated for use in the management of severe spasticity. Spasticity is a major problem that has long challenged traditional medical treatment. While the incidence of spasticity is not known with certainty, it likely affects over half a million people in the United States and over 12 million worldwide. Spasticity is associated with some very common neurological disorders such as: multiple sclerosis, stroke, cerebral palsy, spinal cord and brain injuries. Chronic spasticity seriously restricts normal daily activities and reduces the quality of life for many patients.
- Conditions
- Spasticity
- Being tested
- Prometra Programmable Implantable Pump System
- Keywords
- neurological disorders, multiple sclerosis, stroke, cerebral palsy, spinal cord, brain injuries, neurodegenerative diseases
- Medical subject headings
- Muscle Spasticity, Nervous System Diseases, Multiple Sclerosis, Stroke, Cerebral Palsy, Brain Injuries, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometra Programmable Implantable Pump SystemDevice
The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer.
| Study group | Role | What they receive |
|---|---|---|
| Spasticity. Baclofen | Experimental | This study is a non-randomized, open-label, multi-center study of the Prometra Programmable Implantable Pump System in the administration of Lioresal® intrathecal (baclofen) in patients suffering from severe muscle spasticity of spinal origin. Receives: Device: Prometra Programmable Implantable Pump System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale
Measured: 3 months
Secondary outcomes (1)
Secondary Endpoints include: Change in overall spasm frequency as measured by the Penn Spasm Frequency Scale. Change in overall Quality of Life as measured by the SF 36 and PSQI. SAE-free survival. DRAE-free survival. Tabulation of device complications.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Study was never started. Full IDE-approval not obtained. new IDE will be submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flowonix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Levy, MD, PhD, Principal investigator, Northwestern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051128
- Sponsor's protocol ID
- G090276
- Acronym
- CIBI
- Status last verified
- Mar 2015
- First submitted
- 15 Jan 2010
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Intrathecal Baclofen Infusion for the Management of Chronic Spasticity
- ClinicalTrials.gov ID
- NCT01051128
- Acronym / sponsor ID
- CIBI / G090276
- Conditions
- Spasticity
- Keywords
- neurological disorders, multiple sclerosis, stroke, cerebral palsy, spinal cord, brain injuries, neurodegenerative diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started. Full IDE-approval not obtained. new IDE will be submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Flowonix MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Jan 2010 (estimated)
- 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.
The purpose of this clinical investigation is to demonstrate product performance of the Prometra Programmable Pump System in the delivery of intrathecal Lioresal® (baclofen) for the management of severe spasticity.
Detailed description
The Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. Lioresal Intrathecal (baclofen) is indicated for use in the management of severe spasticity. Spasticity is a major problem that has long challenged traditional medical treatment. While the incidence of spasticity is not known with certainty, it likely affects over half a million people in the United States and over 12 million worldwide. Spasticity is associated with some very common neurological disorders such as: multiple sclerosis, stroke, cerebral palsy, spinal cord and brain injuries. Chronic spasticity seriously restricts normal daily activities and reduces the quality of life for many patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spasticity. Baclofen | Experimental | Device: Prometra Programmable Implantable Pump SystemThis study is a non-randomized, open-label, multi-center study of the Prometra Programmable Implantable Pump System in the administration of Lioresal® intrathecal (baclofen) in patients suffering from severe muscle spasticity of spinal origin. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The overall goal of this study is to choose patients most likely to experience therapeutic success while reducing the likelihood of risks, complications and adverse events.
- Patients meeting all of the following criteria will be eligible for enrollment in the study:
- Patient with a history of severe chronic spastic hypertonia in the lower extremities lasting at least 6 months who:
- Patient is >21 years of age
- Patient, or legally authorized representative (LAR), has provided written informed consent to participate in the study
Key exclusion criteria (13 listed)
- Patient has MRI of the spine documenting structural abnormality preventing adequate CSF flow. (If the patient has a medical condition that contraindicates screening MRI, the investigator should proceed with the closest appropriate study i.e. CT scan, X-ray, to rule out any spinal abnormalities that would prevent intrathecal drug administration.)
- Patient's anatomy is not large enough to accommodate the pump's size and weight.
- Patient has a systemic infection.
- Patient has renal insufficiency as evidenced by a baseline serum creatinine of >2.0 mg/dl.
- Patient has a history of a bleeding disorder.
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 |
|---|---|---|
| Prometra Programmable Implantable Pump SystemThe Prometra Programmable Pump is a battery-operated, implantable, programmable infusion pump that dispenses drug solution into the intrathecal space through an implanted infusion catheter. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. | Device | Spasticity. Baclofen |
Primary outcome
The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale
Time frame: 3 months
1 secondary outcome
Secondary Endpoints include: Change in overall spasm frequency as measured by the Penn Spasm Frequency Scale. Change in overall Quality of Life as measured by the SF 36 and PSQI. SAE-free survival. DRAE-free survival. Tabulation of device complications.
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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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.
Robert Levy, MD, PhD principal investigator
Northwestern University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prometra Programmable Implantable Pump System in people with Spasticity, run by Flowonix Medical.
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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is: A change in the average lower extremity spasticity score as measured by the Modified Ashworth Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.