Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alcyone Therapeutics, Inc
Study ID
NCT05866419
Status
Recruiting
Apply to this trial

Conditions

  • Scoliosis
  • Spinal Muscular Atrophy
  • Spine Deformity

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ThecaFlex DRx System — DEVICE
    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 Details

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.

Key Dates

Start date
Nov 27, 2023
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ThecaFlex DRx Port and Catheter System
    Subjects who meet all of the inclusion and none of the exclusion would be eligible to receive the ThecaFlex DRx Port and Catheter System.

Primary Outcome Measure

The proportion of subjects with successful Implantation of the ThecaFlex DRx™ Port and Catheter [ Time Frame: 12 Months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013
Kathleen Nagaran Hildebrand
[email protected]
602-406-7031
Shafeeq Ladha, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital Orange CountyOrangeCalifornia92868
Melina Thaxton
[email protected]
Stanford Medical CenterPalo AltoCalifornia94301
Habib Mofakham
[email protected]
Rady Children's HospitalSan DiegoCalifornia92037
Elizabeth Moreno
[email protected]
Nemours Children's Hospital, FloridaOrlandoFlorida32827
Debbie Berry
[email protected]
Lurie Childrens HospitalChicagoIllinois60611
Raven HIll
[email protected]
Boston Children's HospitalBostonMassachusetts02115
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Natasha Schafer
[email protected]
Columbia University Irving Medical Center/NewYork Presbyterian HospitalNew YorkNew York10032
Kimbery Berry
[email protected]
212-342-3038
UH Rainbow Babies and Children's HospitalClevelandOhio44106
Abigail Schlosser
[email protected]
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033
Chelsea Emrick
[email protected]
Children's Hospital PhiladelphiaPhiladelphiaPennsylvania19104
Samantha Gogel
[email protected]
Texas Children's HospitalHoustonTexas77030
University of VirginiaCharlottesvilleVirginia22903
Chelsea Masterson
[email protected]
Childrens Hospital of the King's DaughtersNorfolkVirginia23510
Erika Paradiso
[email protected]

Find similar trials in Phoenix, AZ

By research site
Barrow Neurological Institute· Phoenix, AZChildren's Hospital Orange County· Orange, CAStanford Medical Center· Palo Alto, CARady Children's Hospital· San Diego, CANemours Children's Hospital, Florida· Orlando, FLLurie Childrens Hospital· Chicago, IL

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