Clinical trials: Intrathecal Drug Delivery
Pain Control
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
- Trial name
- NCT05552443
- Testing
- Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg, Hydromorphone 3 mcg/kg
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Mayo Clinic
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Amyotrophic Lateral Sclerosis, ALS
Safety and Efficacy Study of Autologous Bone Marrow Derived Stem Cell Treatment in Amyotrophic Lateral Sclerosis
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived stem cells("HYNR-CS inj"), through intrathecal delivery for the treatment in patients with ALS. This study consists of 2 steps.
- Trial name
- NCT01363401
- Testing
- HYNR-CS inj, Control group
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Corestemchemon, Inc.
Huntingtons Disease
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)
- Trial name
- NCT03761849
- Testing
- RO7234292
- Where
- 96 sites in United States, Argentina and 16 more
- Volunteers
- 899 people
- Sponsor
- Hoffmann-La Roche
Sanfilippo Syndrome, Mucopolysaccharidosis (MPS)
An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.
This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy…
- Trial name
- NCT02350816
- Testing
- HGT-1410
- Where
- 8 sites in United States, France and 5 more
- Volunteers
- 17 people
- Sponsor
- Shire
Pain, Cesarean Section
Intrathecal Hydromorphone for Pain Control After Cesarean Section
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph).
- Trial name
- NCT02096003
- Testing
- Intrathecal morphine, Intrathecal hydromorphone
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Analgesia, Obstetrical, Obstetric Surgical Procedures
Spinal Morphine vs. Hydromorphone for Pain Control After Cesarean Delivery
Intrathecal (IT) opioids are commonly administered with local anesthetic during spinal anesthesia for post-Cesarean delivery analgesia. Traditionally, IT morphine has been used but the use of IT hydromorphone is growing.
- Trial name
- NCT02789410
- Testing
- Morphine, Hydromorphone
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Mayo Clinic
Pain Management, Spinal Fusion
Intrathecal Morphine Versus Epidural Extended Release Morphine for Pediatric Patients Undergoing Spinal Fusion
This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine).
- Conditions
- Pain Management, Spinal Fusion, Scoliosis
- Trial name
- NCT00880607
- Testing
- Intrathecal morphine, Extended Release Epidural Morphine
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- University of Colorado, Denver
Metachromatic Leukodystrophy (MLD)
A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy
The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to…
- Trial name
- EMBOLDEN (NCT03771898)
- Testing
- SHP611
- Where
- 30 sites in United States, Argentina and 12 more
- Volunteers
- 36 people
- Sponsor
- Shire
Multiple Sclerosis
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis
This is a phase II, double-blinded, placebo-controlled, randomized, cross-over Study designed to determine the efficacy of multiple intrathecal administrations of autologous mesenchymal stem cell-derived neural progenitor cells…
- Trial name
- NCT03355365
- Testing
- Intrathecal MSC-NP injection, Intrathecal saline injection
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Tisch Multiple Sclerosis Research Center of New York
Brain and Central Nervous System Tumors
Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma
RATIONALE: Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells.
- Trial name
- NCT00058370
- Testing
- cisplatin, lomustine, vincristine sulfate
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Analgesia, Obstetrical, Cesarean Section
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery.
- Trial name
- NCT02009722
- Testing
- Morphine, Hydromorphone
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Mayo Clinic