SpasticityNCT01712087
Long-term Surveillance of the MedStream Programmable Infusion System
An observational study of Spasticity, run by Codman & Shurtleff at 2 sites in United States.
Trial summary
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- MedStream Programmable Infusion System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2012to 17 Dec 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen are potential study candidates and will be screened for study eligibility. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled into this study.
Who may be able to join
- The subject is a viable candidate for "de novo" or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump.
- The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part 50.
- The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant.
- The subject has an anticipated life expectancy of 24 months or greater.
- The subject must be 18 years of age or older at time of MedStream implant procedure.
- The subject is of sufficient body size to accommodate pump placement, in the opinion of the Investigator.
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- The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40 mL pump, MedStream approved catheter(s) and MedStream accessories.
- The Investigator intends to use Baclofen in the pump for treatment of severe spasticity
- The subject is capable of self-reporting spasm frequency.
Who cannot join
- Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period.
- Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment.
- Evidence of a fever or infection within 10 days prior to the surgical implant procedure that, in the opinion of the Investigator might impact a successful pump implant.
- The subject has known hypersensitivity/allergies or contraindication to Baclofen or the materials in the infusion pump or catheter(s).
- The subject has a co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements or, which might impact the scientific integrity of the study.
- The subject has a rapid degenerative neurological disease such as lateral sclerosis, amyotrophic lateral sclerosis (ALS), rapidly progressive Multiple Sclerosis, inherited or rapidly progressive leukodystrophies, Moyamoya disease, cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL), thrombophilias, rapidly progressive autoimmune disorders, or any disorder where progression of the underlying spinal cord or a central nervous system (CNS) disease is expected to progress significantly over the next 3 years
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- Subject is a prisoner.
- Subject was previously enrolled in this study.
- Subject is pregnant or breastfeeding. (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methodist Hospital Research Institute
Houston, Texas, 77030
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.
- Conditions
- Spasticity
- Being tested
- MedStream Programmable Infusion System
- Keywords
- spasticity, muscle spasticity, muscle rigidity, motor neuron disease, hyperreflexia
- Medical subject headings
- Muscle Spasticity, Muscle Rigidity, Motor Neuron Disease, Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedStream Programmable Infusion SystemDevice
Also called MedStream, MedStream Pump, MedStream programmable pump, MedStream Intrathecal Infusion System
Intrathecal Infusion of Baclofen in the Treatment of Spasticity
| Study group | Role | What they receive |
|---|---|---|
| MedStream System Implants | All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen. Receives: Device: MedStream Programmable Infusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit
Measured: 24 Months
Secondary outcomes (9)
MedStream system-related AEs occurring from 24 to 36 months
Measured: 36 Months
Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.
Device-related AEs occurring in subjects with both MedStream and non-MedStream devices used or implanted during the course of the study. Device refers to the pump and intrathecal catheters
Measured: 24 Months
Procedure-related AEs
Procedure-related AEs including, but not limited to the following study procedures: MedStream system implant, pump refill and bolus, and reprogramming. If non-MedStream devices or components are utilized in these procedures, this will be described.
Measured: 24 Months
Drug-related AEs associated with intrathecal Baclofen
Measured: 24 Months
Drug-related AEs associated with other intrathecally-administered medications
Measured: 24 Months
Disease-related AEs associated with pre-existing conditions
Disease-related AEs associated with pre-existing conditions that demonstrate a significant worsening of the disease or an increase in the frequency of episodes since baseline, as determined by the investigator.
Measured: 24 Months
Serious Adverse Events (SAEs)
Measured: 36 Months
Unanticipated Adverse Device Effects (UADEs)
Measured: 24 Months
The secondary effectiveness endpoints will be long-term effectiveness of MedStream System
Long-term effectiveness as demonstrated by scores on the Ashworth Scale (lower extremity) and the frequency and severity components of the Penn Spasm Frequency Scale (PSFS) measured pre-implant, post-implant and at each of the protocol-specified study visits.
Measured: 24 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study start1 Oct 2012
- Primary completion17 Dec 2017
- Study completion17 Dec 2017
Why it stopped: Lack of enrollment
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codman & Shurtleff
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan T Megerian, MD, Study director, Codman & Shurtleff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712087
- Sponsor's protocol ID
- NM-PMK-1001
- Status last verified
- Jan 2019
- First submitted
- 19 Oct 2012
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity
- ClinicalTrials.gov ID
- NCT01712087
- Acronym / sponsor ID
- NM-PMK-1001
- Conditions
- Spasticity
- Keywords
- spasticity, muscle spasticity, muscle rigidity, motor neuron disease, hyperreflexia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Codman & ShurtleffIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 23 Oct 2012 (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.
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedStream System Implants | – | Device: MedStream Programmable Infusion SystemAll subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen are potential study candidates and will be screened for study eligibility. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled into this study.
Key inclusion criteria (9 listed)
- The subject is a viable candidate for "de novo" or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump.
- The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part 50.
- The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant.
- The subject has an anticipated life expectancy of 24 months or greater.
- The subject must be 18 years of age or older at time of MedStream implant procedure.
Key exclusion criteria (9 listed)
- Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period.
- Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment.
- Evidence of a fever or infection within 10 days prior to the surgical implant procedure that, in the opinion of the Investigator might impact a successful pump implant.
- The subject has known hypersensitivity/allergies or contraindication to Baclofen or the materials in the infusion pump or catheter(s).
- The subject has a co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements or, which might impact the scientific integrity of the study.
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 |
|---|---|---|
| MedStream Programmable Infusion SystemAlso: MedStream, MedStream Pump, MedStream programmable pump, MedStream Intrathecal Infusion SystemIntrathecal Infusion of Baclofen in the Treatment of Spasticity | Device | MedStream System Implants |
Primary outcome
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
Time frame: 24 Months
The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit
9 secondary outcomes
MedStream system-related AEs occurring from 24 to 36 months
Time frame: 36 Months
Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.
Time frame: 24 Months
Procedure-related AEs
Time frame: 24 Months
Drug-related AEs associated with intrathecal Baclofen
Time frame: 24 Months
Drug-related AEs associated with other intrathecally-administered medications
Time frame: 24 Months
Disease-related AEs associated with pre-existing conditions
Time frame: 24 Months
Serious Adverse Events (SAEs)
Time frame: 36 Months
Unanticipated Adverse Device Effects (UADEs)
Time frame: 24 Months
The secondary effectiveness endpoints will be long-term effectiveness of MedStream System
Time frame: 24 Month
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
Jonathan T Megerian, MD study director
Codman & Shurtleff
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, run by Codman & Shurtleff at 2 sites in United States.
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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
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 the incidence of MedStream system-related Adverse Events (AE) (time frame: 24 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 23 Jan 2019.