Clinical trials: Intrathecal Drug Delivery
Severe Spasticity
SISTERS: Spasticity In Stroke Study - Randomized Study
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who…
- Trial name
- SISTERS (NCT01032239)
- Testing
- intrathecal baclofen
- Where
- 25 sites in United States, Austria and 7 more
- Volunteers
- 61 people
- Sponsor
- MedtronicNeuro
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
Healthy
Effect of Spinal Ketorolac After Acute Opioid Exposure
This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury.
- Trial name
- NCT00693160
- Testing
- ketorolac, remifentanil, Capsaicin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Wake Forest University
Lumbar Post-Laminectomy Syndrome, Chronic Low Back Pain
Determining the Prognostic Value of Continuous Intrathecal Infusion
The purpose of this study will be to determine the efficacy and the prognostic value of a continuous intrathecal prognostic infusion test in an in-hospital setting for selecting patients who would have better long term outcomes…
- Conditions
- Lumbar Post-Laminectomy Syndrome, Chronic Low Back Pain, Vertebral Compression Fracture, Failed Back Surgery Syndrome
- Trial name
- NCT03523000
- Testing
- Continuous intrathecal prognostic infusion test, Bupivacaine, Fentanyl
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University Hospitals Cleveland Medical Center
Neoplastic Meningitis, Lymphoma, B Cell
DepoCyt for Active Lymphomatous or Leukemic Meningitis
The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt. The safety of DepoCyt, the number of people who respond well to the study drug, and the response of…
- Trial name
- NCT00523939
- Testing
- cytarabine liposome injection
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Chronic Pain
Intrathecal Morphine Compared to Conventional Medical Management for Pain Control and Opioid-related Side Effects
This study compares two different ways to treat pain. The two ways are: 1. continuing to take current pain medication(s) or 2. receiving morphine, a pain medication from a drug pump (a system to deliver drug to your body) that is…
- Trial name
- CONVERT-TDD (NCT01924182)
- Testing
- SynchroMed Infusion System and Intrathecal Morphine Sulfate, Conventional Medicine
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- MedtronicNeuro
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.
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
Cerebral Palsy, Multiple Sclerosis
Measuring Signatures in the Fluid Surrounding the Spinal Cord in Patients Who Have Problems With Intrathecal Drug Delivery
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
- Conditions
- Cerebral Palsy, Multiple Sclerosis, Traumatic Brain Injury, Spinal Cord Injury
- Trial name
- NCT01117090
- Where
- 2 sites in United States
- Volunteers
- 47 people
- Sponsor
- MedtronicNeuro
Niemann-Pick Disease, Type C1
Combined Intrathecal and Intravenous VTS-270 Therapy for Liver and Neurological Disease Associated With Niemann-Pick Disease, Type C1
Background: For people who have Niemann-Pick disease, type C1 (NPC1), cholesterol and other fats have trouble moving out of liver and other tissue cells. This makes the cells sick.
- Trial name
- NCT03887533
- Testing
- VTS-270
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pain, Pancreatic Cancer
Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
RATIONALE: Giving medications in different ways may change their effectiveness in controlling pain. It is not yet known whether intrathecal therapy is more effective than standard therapy in controlling pain in patients with…
- Trial name
- NCT00660348
- Testing
- morphine sulfate, Medtronic intrathecal pump
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
AMN, AMN Gene Mutation
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)
This is a Phase 1/2 randomized, blinded, dose-escalation study to evaluate the safety and efficacy of intrathecal (IT) administration of SBT101, a recombinant adeno-associated virus serotype 9 (AAV9) containing a functional copy…
- Conditions
- AMN, AMN Gene Mutation, X-ALD
- Trial name
- PROPEL (NCT05394064)
- Testing
- SBT101 Treatment
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 9 people
- Sponsor
- SwanBio Therapeutics, Inc.
Postdural Puncture Headache, Post-Lumbar Puncture Headache
Incidence of Headache Following an Unintentional Dural Puncture
The purpose of this study is to evaluate the use of intrathecal morphine administration following an unintentional dural puncture, to decrease the incidence of post dural puncture headaches (PDPH) in obstetric patients.
- Conditions
- Postdural Puncture Headache, Post-Lumbar Puncture Headache, Cerebrospinal Fluid Leaks
- Trial name
- NCT01977898
- Testing
- Morphine, Saline
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Northwestern University
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
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
Huntingtons Disease
A Study to Investigate the Pharmacokinetics and Pharmacodynamics of RO7234292 (RG6042) in CSF and Plasma, and Safety and Tolerability Following Intrathecal Administration in Patients With Huntington's Disease
Study BP40410 is an open-label, adaptive multiple-dose clinical study designed to characterize the PK of RO7234292 (RG6042) in plasma and CSF as well as the acute time course and recovery profile of CSF mHTT lowering in response…
- Trial name
- NCT04000594
- Testing
- RO7234292 (RG6042)
- Where
- 3 sites in Netherlands, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Hoffmann-La Roche
Tay-Sachs Disease, Sandhoff Disease
A Dose-escalation and Safety & Efficacy Study of AXO-AAV-GM2 in Tay-Sachs or Sandhoff Disease
The AXO-GM2-001 study is an open-label, two-stage clinical trial designed to evaluate safety and dose-escalation (Stage 1) and safety and efficacy (Stage 2) of a bilateral thalamic and intracisternal/intrathecal infusion of…
- Trial name
- NCT04669535
- Testing
- AXO-AAV-GM2 Starting Dose, AXO-AAV-GM2 Low Dose, AXO-AAV-GM2 Middle Dose
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Terence Flotte
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
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire