Spinal Muscular AtrophyPIERRENCT05866419
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
A study testing ThecaFlex DRx System in people with Spinal Muscular Atrophy and Spine Deformity, run by Alcyone Therapeutics, Inc at 21 sites in 5 countries.
Trial summary
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- What is being tested?
- ThecaFlex DRx System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 27 Nov 2023to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is 3 years or older
- Subject is diagnosed with SMA and is a candidate for Spinraza treatment as indicated in country-specific label
- Subject resistant to lumbar puncture (LP), where resistance is defined as:
- Subject with respiratory issues or other comorbidities who is at an increased risk for complications due to the need for repeat anesthesia and imaging radiation exposure to safely perform LP; or
- Subjects for whom the treating physician determines implantation of the ThecaFlex DRx™ System is otherwise in the subject's best interest
- Subject has been prescribed nusinersen via chronic intrathecal bolus administration in accordance with the country-specific drug labeling
Show all 9Show fewer
- Subject, per Investigator discretion, is able to undergo a percutaneous or open surgical procedure for index port and catheter implantation where at least 7 cm of the ThecaFlex DRx system catheter will be placed intrathecally
- Subject (or subject's legally authorized representative) is willing and able to provide written informed consent; and
- Subject and parent/caregiver able and willing to complete all clinical investigation procedures, measurements, and visits.
Who cannot join
- Subject meets any of the contraindications for use of the ThecaFlex DRx System as outlined in the ThecaFlex DRx System Instructions for Use
- Presence or history of (< 6 months prior to the procedure): an implanted microinfusion pump, intrathecal catheter, or other intrathecal drug delivery devices/component, or implanted shunt for drainage of cerebrospinal fluid (CSF), or reservoir in the CSF space (note: any ThecaFlex Port and Catheter System must not be placed in the same location as a previous indwelling port and catheter)
- Subject is pregnant or nursing or plans to become pregnant during the course of the clinical investigation, or is a woman of childbearing potential or a man of reproductive age who is unwilling or unable to practice contraception, as described in Section 14.10.
- Any condition or event, which in the opinion of the Investigator may adversely affect the safety and effective implantation and use of the ThecaFlex DRx system or confound the clinical investigation, including:
- Severe structural impediment that may preclude safe implantation of the catheter and port
- Major medical events (as defined per investigator's discretion) within 60 days prior to screening; or
Show all 22Show fewer
- Relevant surgeries (e.g., head and neck, back, etc.) within 60 days prior to screening or planned during the duration of the clinical investigation
- Space-occupying lesion with mass effect
- Posterior fossa mass
- Arnold-Chiari malformation
- Coagulation abnormalities and/or thrombocytopenia
- Insufficient or inadequate skin or underlying fat to adequately protect the port or enough surface area to allow the skin to close safely
- Subject is contraindicated for administration of nusinersen per its approved country-specific labeling
- History of intrathecal granuloma formation
- History of bacterial meningitis or aseptic meningitis within 6 months of screening
- History of tumors or other spinal abnormalities documented by magnetic resonance imaging (MRI) or computed tomography (CT) that would interfere with the catheter implantation procedures or CSF circulation
- History of hydrocephalus
- Diagnosed degenerative muscular disease other than SMA
- History of depression, cognitive impairment, or another psycho-behavioral problem that in the opinion of the Investigator may preclude safe participation in the clinical investigation and
- Serious medical condition that, in the opinion of the investigator, may lead to reduced life expectancy beyond 12 months.
- Subject is involved in another Investigation Device Exemption Study.
- Subject has clinically meaningful immunosuppression, in the opinion of the investigator, either from therapy or a comorbid condition, which, in the opinion of the investigator, makes them a poor surgical candidate due to increased risk of infection.
Trial locations and contacts
21 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 5 countries
United States15 sites, 15 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Adam Porter, adam.porter@childrens.harvard.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Chelsea Masterson
CDM5FA@uvahealth.org
- Recruiting
Lurie Childrens Hospital
Chicago, Illinois, 60611
Raven HIll
rhill@luriechildrens.org
- Recruiting
UH Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Abigail Schlosser, Abigail.Schlosser@UHhospitals.org
- Recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Natasha Schafer, natasha.schafer@corewellhealth.org
- Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Chelsea Emrick, awinters2@pennstatehealth.psu.edu
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Sarah Wisor, sxwisor@texaschildrens.org
- Recruiting
Columbia University Irving Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
Kimbery Berry, 212-342-3038, KB2996@cumc.columbia.ediu
- Recruiting
Childrens Hospital of the King's Daughters
Norfolk, Virginia, 23510
Erika Paradiso, Erika.Paradiso@chkd.org
- Recruiting
Children's Hospital Orange County
Orange, California, 92868
Melina Thaxton, MelinaThaxton@choc.org
- Recruiting
Nemours Children's Hospital, Florida
Orlando, Florida, 32827
Debbie Berry, debbie.berry@nemours.org
- Recruiting
Stanford Medical Center
Palo Alto, California, 94301
Habib Mofakham, neuromuscularresearch@stanford.edu
- Recruiting
Children's Hospital Philadelphia
Philadelphia, Pennsylvania, 19104
Samantha Gogel, Gogels@chop.edu
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
Kathleen Nagaran Hildebrand, (602) 406 7031, kathleen.nagaranhildebrand900@commonspirit.org
Shafeeq Ladha, MD
- Recruiting
Rady Children's Hospital
San Diego, California, 92037
Elizabeth Moreno, e4moreno@health.ucsd.edu
Poland2 sites, 2 recruiting
- Recruiting
Specialised Hospital Ludwika Rydygiera
Krakow
Ryszard Nowak, badaniakliniczne@rydygierkrakow.pl
- Recruiting
Research Institute of Polish Mother's Memorial Hospital
Lodz
Lukasz Przyslo, lukasz.przyslo@iczmp.edu.pl
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid
María del Mar García Romero, mmar.garcia.romero@salud.madrid.org
- Recruiting
Hospital Universitario y Politecnico la Fe de Valencia
Valencia, 46026
Nancy Ñungo Garzon, carolina_nungo@iislafe.es
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Essen
Essen
Jaqueline Lipka, jaqueline.lipka@uk-essen.de
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
Lee Tuddenham, lee.tuddenham@nhs.net
About this study
Official title: Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE Trial (PIERRE)
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.
Read the detailed description
This is a multicenter, multi-national, prospective, non-randomized, single arm, group sequential design, pivotal clinical investigation (device exemption study) to assess the safety and performance of the ThecaFlex DRx™ System in subjects with SMA.
The subject population will include subjects aged ≥ 3 years with SMA who are considered candidates for intrathecal port and catheter implantation because they require chronic, bolus intrathecal administration of necessary therapy, and who meet all the inclusion/exclusion criteria for the clinical investigation.
After a screening period of up to 200 days, all enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant.
In agreement with the nusinersen dosing information, the treatment frequency will be adapted for non-naïve and naïve subjects:
Subjects who are not naïve to nusinersen should have nusinersen maintenance doses administered via the implant every 4 months (i.e., 4, 8, and 12 months after their last nusinersen dose, before enrollment in the clinical investigation).
Subjects who are naïve to nusinersen will have their loading and maintenance doses administered via the device according to the drug labeling.
A DMC and Clinical Events Committee (CEC), independent of each other and the Sponsor, will be used to perform ongoing consistent adjudication of events related to the safety throughout the entire duration of the clinical investigation and to periodically review data that relate to the safety of the study.
The clinical investigation will enroll 90 subjects. The clinical investigation incorporates a lead-in phase which consists of 10 subjects enrolled, implanted, and followed for 30-days. Enrollment for the lead-in phase is expected to take approximately 6 to 9 months, at which point the Data Monitoring Committee (DMC) will review the data for safety and approve continuation of enrollment. The second phase of enrollment is expected to take approximately 12 to 15 months.
Individual subjects are anticipated to be enrolled in the clinical investigation for approximately 37 months. The total duration of this clinical investigation is estimated to be approximately 60 months.
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Being tested
- ThecaFlex DRx System
- Medical subject headings
- Muscular Atrophy, Spinal, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThecaFlex DRx SystemDevice
The ThecaFlex DRx™ System consists of an implantable intrathecal catheter, and an implantable subcutaneous port, designed specifically to meet the implantation, Cerebrospinal Fluid (CSF) aspiration, and intrathecal delivery and dosing needs of patients (aged ≥ 3 years) requiring repeated/on-going intermittent chronic bolus intrathecal treatment for life threatening, debilitating Central Nervous System (CNS) disorders who are precluded from Lumbar Puncture (LP) due to complex spine conditions, or who are resistant to LP for therapy administration or CSF aspiration.
| Study group | Role | What they receive |
|---|---|---|
| ThecaFlex DRx Port and Catheter System | Experimental | Subjects who meet all of the inclusion and none of the exclusion would be eligible to receive the ThecaFlex DRx Port and Catheter System. Receives: Device: ThecaFlex DRx System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with successful Implantation of the ThecaFlex DRx™ Port and Catheter
The primary outcome measures the proportion of subjects with successful implantation of the ThecaFlex DRx™ Port and Catheter System who are able to receive successful intrathecal therapy infusion(s).
Measured: 12 Months
The proportion of subjects with successful Intrathecal Therapy Infusion(s) through 12 months
Measured: 12 Months
Secondary outcomes (5)
Proportion of subjects with reduced anesthesia and radiation exposure compared to repeat LP for nusinersen infusion in SMA subjects.
Measured: 12 months
Incidence of device-related adverse events (AEs)/complications through 12 months
Measured: 12 months
Incidence of procedural complications through 12 months
Measured: 12 months
Incidence of nusinersen-related AEs
Measured: 12 months
Mean duration of radiation exposure from implant through 12-month follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start27 Nov 2023
- Primary completionApr 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Muscular AtrophyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcyone Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866419
- Sponsor's protocol ID
- QT-0179
- Acronym
- PIERRE
- Status last verified
- Aug 2026
- First submitted
- 10 May 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mesina-Estarron I, Abruzzo M, Gomes FC, Thaxton M, Yengo-Kahn A, Stone S, Northam W, Snyder B, Cahill P, Bauer D, Muhonen M. Clinical evaluation of ThecaFlex DRx, a novel implantable catheter-port for intrathecal nusinersen delivery in spinal muscular atrophy: Initial results from the PIERRE-IDE study. J Neuromuscul Dis. 2026 Mar 13:22143602261432303. doi: 10.1177/22143602261432303. Online ahead of print.
PubMed 41830093
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE Trial (PIERRE)
- ClinicalTrials.gov ID
- NCT05866419
- Acronym / sponsor ID
- PIERRE / QT-0179
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Alcyone Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 19 May 2023 (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.
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.
Detailed description
This is a multicenter, multi-national, prospective, non-randomized, single arm, group sequential design, pivotal clinical investigation (device exemption study) to assess the safety and performance of the ThecaFlex DRx™ System in subjects with SMA.
The subject population will include subjects aged ≥ 3 years with SMA who are considered candidates for intrathecal port and catheter implantation because they require chronic, bolus intrathecal administration of necessary therapy, and who meet all the inclusion/exclusion criteria for the clinical investigation.
After a screening period of up to 200 days, all enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant.
In agreement with the nusinersen dosing information, the treatment frequency will be adapted for non-naïve and naïve subjects:
Subjects who are not naïve to nusinersen should have nusinersen maintenance doses administered via the implant every 4 months (i.e., 4, 8, and 12 months after their last nusinersen dose, before enrollment in the clinical investigation).
Subjects who are naïve to nusinersen will have their loading and maintenance doses administered via the device according to the drug labeling.
A DMC and Clinical Events Committee (CEC), independent of each other and the Sponsor, will be used to perform ongoing consistent adjudication of events related to the safety throughout the entire duration of the clinical investigation and to periodically review data that relate to the safety of the study.
The clinical investigation will enroll 90 subjects. The clinical investigation incorporates a lead-in phase which consists of 10 subjects enrolled, implanted, and followed for 30-days. Enrollment for the lead-in phase is expected to take approximately 6 to 9 months, at which point the Data Monitoring Committee (DMC) will review the data for safety and approve continuation of enrollment. The second phase of enrollment is expected to take approximately 12 to 15 months.
Individual subjects are anticipated to be enrolled in the clinical investigation for approximately 37 months. The total duration of this clinical investigation is estimated to be approximately 60 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ThecaFlex DRx Port and Catheter System | Experimental | Device: ThecaFlex DRx SystemSubjects who meet all of the inclusion and none of the exclusion would be eligible to receive the ThecaFlex DRx Port and Catheter System. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is 3 years or older
- Subject is diagnosed with SMA and is a candidate for Spinraza treatment as indicated in country-specific label
- Subject resistant to lumbar puncture (LP), where resistance is defined as:
- Subject has been prescribed nusinersen via chronic intrathecal bolus administration in accordance with the country-specific drug labeling
- Subject, per Investigator discretion, is able to undergo a percutaneous or open surgical procedure for index port and catheter implantation where at least 7 cm of the ThecaFlex DRx system catheter will be placed intrathecally
Key exclusion criteria (22 listed)
- Subject meets any of the contraindications for use of the ThecaFlex DRx System as outlined in the ThecaFlex DRx System Instructions for Use
- Presence or history of (< 6 months prior to the procedure): an implanted microinfusion pump, intrathecal catheter, or other intrathecal drug delivery devices/component, or implanted shunt for drainage of cerebrospinal fluid (CSF), or reservoir in the CSF space (note: any ThecaFlex Port and Catheter System must not be placed in the same location as a previous indwelling port and catheter)
- Subject is pregnant or nursing or plans to become pregnant during the course of the clinical investigation, or is a woman of childbearing potential or a man of reproductive age who is unwilling or unable to practice contraception, as described in Section 14.10.
- Any condition or event, which in the opinion of the Investigator may adversely affect the safety and effective implantation and use of the ThecaFlex DRx system or confound the clinical investigation, including:
- Subject is contraindicated for administration of nusinersen per its approved country-specific labeling
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 |
|---|---|---|
| ThecaFlex DRx SystemThe ThecaFlex DRx™ System consists of an implantable intrathecal catheter, and an implantable subcutaneous port, designed specifically to meet the implantation, Cerebrospinal Fluid (CSF) aspiration, and intrathecal delivery and dosing needs of patients (aged ≥ 3 years) requiring repeated/on-going intermittent chronic bolus intrathecal treatment for life threatening, debilitating Central Nervous System (CNS) disorders who are precluded from Lumbar Puncture (LP) due to complex spine conditions, or who are resistant to LP for therapy administration or CSF aspiration. | Device | ThecaFlex DRx Port and Catheter System |
Primary outcome
The proportion of subjects with successful Implantation of the ThecaFlex DRx™ Port and Catheter
Time frame: 12 Months
The primary outcome measures the proportion of subjects with successful implantation of the ThecaFlex DRx™ Port and Catheter System who are able to receive successful intrathecal therapy infusion(s).
The proportion of subjects with successful Intrathecal Therapy Infusion(s) through 12 months
Time frame: 12 Months
5 secondary outcomes
Proportion of subjects with reduced anesthesia and radiation exposure compared to repeat LP for nusinersen infusion in SMA subjects.
Time frame: 12 months
Incidence of device-related adverse events (AEs)/complications through 12 months
Time frame: 12 months
Incidence of procedural complications through 12 months
Time frame: 12 months
Incidence of nusinersen-related AEs
Time frame: 12 months
Mean duration of radiation exposure from implant through 12-month follow-up
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 41830093Mesina-Estarron I, Abruzzo M, Gomes FC, Thaxton M, Yengo-Kahn A, Stone S, Northam W, Snyder B, Cahill P, Bauer D, Muhonen M. Clinical evaluation of ThecaFlex DRx, a novel implantable catheter-port for intrathecal nusinersen delivery in spinal muscular atrophy: Initial results from the PIERRE-IDE study. J Neuromuscul Dis. 2026 Mar 13:22143602261432303. doi: 10.1177/22143602261432303. Online ahead of print.
- 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.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ThecaFlex DRx System in people with Spinal Muscular Atrophy and Spine Deformity, run by Alcyone Therapeutics, Inc at 21 sites in 5 countries.
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 22 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Poland, Spain, Germany, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janelle Arrambide (857-500-7526, janelle.arrambide@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with successful Implantation of the ThecaFlex DRx™ Port and Catheter (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 NCT05866419, which also lists 1 linked publication.
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 19 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.