Amyotrophic Lateral SclerosisPARADIGMNCT03034317
NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)
A study testing NeuRx DPS in people with Amyotrophic Lateral Sclerosis, run by Synapse Biomedical.
Trial summary
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- NeuRx DPS
- Type of treatment
- 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
- 2 Feb 2017to 12 Feb 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 or older
- Familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria
- Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with phrenic nerve conduction studies
- Chronic hypoventilation was documented by at least one of the following:
- MIP (respiratory muscle strength) less than 60 cmH2O, or
- Forced Vital Capacity (FVC) less than 50% predicted, or
Show all 12Show fewer
- PaCO2 greater than or equal to 45 mmHg, or
- Nocturnal SaO2 (arterial oxygen saturation) less than or equal to 88% for at least five continuous minutes
- Initiation of non-invasive ventilation at or before time of enrollment
- Suitable surgical candidate to receive diaphragm pacing stimulation
- Negative pregnancy test in female participants of childbearing potential (treatment group)
- Informed consent from patient or designated representative
Who cannot join
- FVC less than 45% predicted within 10 days prior to surgery.
- Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study.
About this study
Official title: Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.
Read the detailed description
Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- NeuRx DPS
- Keywords
- Diaphragm Pacing
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuRx DPSDevice
Also called Diaphragm Pacing System
Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted.
| Study group | Role | What they receive |
|---|---|---|
| NeuRx DPS | Active comparator | Subjects who have initiated noninvasive ventilation (NIV) and receive the NeuRx diaphragm pacing system (DPS). Receives: Device: NeuRx DPS |
| No DPS | No intervention | Subjects who have initiated noninvasive ventilation (NIV) and do not receive the DPS device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Compare the survival of patients who initiated noninvasive ventilation (NIV).and who receive DPS to controls without DPS: (1) concurrent controls; (2) historical controls (e.g., Lechtzin and PRO-ACT databases); and (3) virtual controls (Origent).
Measured: 24 months
Secondary outcomes (11)
Relationship between survival time and clinical features of ALS
Determine whether there is a relationship between survival time and ALS onset type.
Measured: 24 months
Relationship between survival time and ALS assessment scores
Determine whether there is a relationship between survival time and Upper Motor Neuron (UMN)/ Lower Motor Neuron (LMN) assessment scores.
Measured: 24 months
Relationship between survival time and onset of weakness from ALS to treatment
Measured: 24 months
Relationship between survival time and ALS treatment interventions
Measured: 24 months
Relationship between survival time and intraoperative strength of contraction
Measured: 24 months
Characterize change in overall and respiratory function
Characterize longitudinal change in overall function (ALSFRS-R) before and after treatment with DPS compared to controls.
Measured: 24 months
Characterize change in respiratory function
Characterize longitudinal change in respiratory function (FVC, MIP) before and after treatment with DPS compared to controls.
Measured: 24 months
Types device and procedure-related adverse events
Measured: 24 months
Frequency of device and procedure-related adverse events
Measured: 24 months
Types of respiratory serious adverse events
Measured: 24 months
Frequency of respiratory adverse events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start2 Feb 2017
- Primary completion8 Feb 2018
- Study completion12 Feb 2018
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synapse Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Miller, MD, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034317
- Sponsor's protocol ID
- 20-1000-51
- Acronym
- PARADIGM
- Status last verified
- Mar 2020
- First submitted
- 13 Jan 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Concurrent-Controlled, On-Label Study of the NeuRx Diaphragm Pacing System (DPS) in Participants With Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT03034317
- Acronym / sponsor ID
- PARADIGM / 20-1000-51
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Diaphragm Pacing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synapse BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 27 Jan 2017 (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 research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.
Detailed description
Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NeuRx DPS | Active comparator | Device: NeuRx DPSSubjects who have initiated noninvasive ventilation (NIV) and receive the NeuRx diaphragm pacing system (DPS). |
| No DPS | No intervention | –Subjects who have initiated noninvasive ventilation (NIV) and do not receive the DPS device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 21 or older
- Familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria
- Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with phrenic nerve conduction studies
- Chronic hypoventilation was documented by at least one of the following:
- Initiation of non-invasive ventilation at or before time of enrollment
Key exclusion criteria (2 listed)
- FVC less than 45% predicted within 10 days prior to surgery.
- Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this 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 |
|---|---|---|
| NeuRx DPSAlso: Diaphragm Pacing SystemPatients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted. | Device | NeuRx DPS |
Primary outcome
Survival
Time frame: 24 months
Compare the survival of patients who initiated noninvasive ventilation (NIV).and who receive DPS to controls without DPS: (1) concurrent controls; (2) historical controls (e.g., Lechtzin and PRO-ACT databases); and (3) virtual controls (Origent).
11 secondary outcomes
Relationship between survival time and clinical features of ALS
Time frame: 24 months
Relationship between survival time and ALS assessment scores
Time frame: 24 months
Relationship between survival time and onset of weakness from ALS to treatment
Time frame: 24 months
Relationship between survival time and ALS treatment interventions
Time frame: 24 months
Relationship between survival time and intraoperative strength of contraction
Time frame: 24 months
Characterize change in overall and respiratory function
Time frame: 24 months
Characterize change in respiratory function
Time frame: 24 months
Types device and procedure-related adverse events
Time frame: 24 months
Frequency of device and procedure-related adverse events
Time frame: 24 months
Types of respiratory serious adverse events
Time frame: 24 months
Frequency of respiratory adverse events
Time frame: 24 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 26 Mar 2020.
- Individual participant dataSharing planned: No
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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 Miller, MD principal investigator
California Pacific Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing NeuRx DPS in people with Amyotrophic Lateral Sclerosis, run by Synapse Biomedical.
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 12 inclusion and 2 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 26 Mar 2020. 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.
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?
Survival (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 26 Mar 2020.