Clinical trials: Intrathecal Drug Delivery
GM2 Gangliosidosis, Tay Sachs Disease
Long-Term Follow-Up of Subjects Treated With AXO-AAV-GM2 for Tay-Sachs or Sandhoff Disease
This study is to continue Long-Term Follow-Up of Patients who were previously treated with AXO-AAV-GM2 Gene Therapy as treatment for Tay-Sachs or Sandhoff Disease to follow the subjects through 5 years after their initial gene…
- Conditions
- GM2 Gangliosidosis, Tay Sachs Disease, Sandhoff Disease
- Trial name
- NCT06614569
- Testing
- AXO-AAV-GM2
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Terence Flotte
Healthy
Glymphatic Kinetics In Healthy Adult Volunteers
This study is being done in order to see how gadolinium-based MRI contrast (Magnevist) travels through the central nervous system (CNS) when injected through the spinal column, and to compare differences between two age groups…
- Trial name
- NCT03218111
- Testing
- MR Imaging, CT-guidance
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Pregnancy
Intrathecal Hydromorphone for Labor Analgesia
The objective of this study is to evaluate the effect of intrathecal hydromorphone on the duration of labor analgesia and the incidence of epidural-associated temperature increase in laboring parturients.
- Trial name
- LITH (NCT02277782)
- Testing
- Hydromorphone, Hyperbaric bupivacaine, Fentanyl
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Brigham and Women's Hospital
Acute Lymphoblastic Leukemia
Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
The aim of this clinical study in adult ALL is to compare by risk category (1) the feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free survival in relation to the achievement of an early MRD…
- Trial name
- NCT00795756
- Testing
- liposome-encapsulated cytarabine (DepoCyte), Triple intrathecal therapy (TIT)
- Where
- 16 sites in Italy
- Volunteers
- 145 people
- Sponsor
- Northern Italy Leukemia Group
Aneurysmal Subarachnoid Hemorrhage
Early Lumbar Drainage Plus Intrathecal Urokinase in Severe Aneurysmal Subarachnoid Hemorrhage (LD-ITUK)
The LD-ITUK is a multicenter, prospective, randomized, double-blind, blind endpoint, placebo-control design trial. All eligible patients with the diagnosis of severe aSAH will be randomly assigned to the treatment group or the…
- Trial name
- NCT06284642
- Testing
- Urokinase
- Where
- 25 sites in China
- Volunteers
- 424 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
HER2-negative Breast Cancer, Leptomeningeal Metastasis
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination…
- Trial name
- NCT06230055
- Testing
- Ommaya reservoir, Systematic chemotherapy, Intrathecal chemotherapy
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Fudan University
Chronic Neuropathic Pain
Safety and Tolerability Study of ST-503 for Refractory Pain Due to Peripheral Neuropathy (Small Fiber Predominant, SFN)
This research is being done to study a possible treatment for refractory pain due to small fiber neuropathy (SFN). ST-503 is intended to deliver a modified copy of the gene which will ideally repress Nav1.7 tissue-related pain…
- Trial name
- NCT06980948
- Testing
- ST-503
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Sangamo Therapeutics
Leukemia
Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells.
- Trial name
- NCT00019409
- Testing
- asparaginase, cyclophosphamide, cytarabine
- Where
- 6 sites in United States, India
- Sponsor
- National Institutes of Health Clinical Center (CC)
Post Cesarean Section Pain
Optimal Intrathecal Morphine Dose for Better Post Cesarean Section Analgesia
Central neuraxial blocks (CNBs) remain the preferred anesthetic technique for cesarean section, with single shot spinal anesthesia (SSSA) being the standard practice at investigator's institute unless contraindicated.
- Trial name
- Analgesia (NCT07560501)
- Testing
- 0.5% bupivacaine heavy with fentanyl, 0.5% bupivacaine heavy with fentanyl plus morphine 50 mcg, 0.5% bupivacaine heavy with fentanyl plus morphine100 mcg
- Volunteers
- 180 people
- Sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
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
Spinal Muscular Atrophy (SMA)
Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular Atrophy
The primary objective of the study is to evaluate anxiety level during intrathecal administration (IT) under standard of care (SOC) and virtual reality (VR) conditions using a reliable self-rating scale.
- Trial name
- REALITY (NCT05354414)
- Testing
- Virtual reality, Standard of Care
- Where
- 12 sites in France
- Volunteers
- 63 people
- Sponsor
- Biogen
Ataxia Telangiectasia
Safety and Efficacy of Mutation-targeted Precision Genetic Therapy for Ataxia-Telangiectasia (A-T)
This project aims to evaluate the safety and efficacy of precision genetic therapy for patients with Ataxia-telangiectasia (A-T), a rare neurodegenerative disease caused by mutations in the ATM gene.
- Trial name
- NCT07215416
- Testing
- Antisense oligonucleotide targeting the ATM gene
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Timothy Yu
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
Post Dural Puncture Headache
Post Dural Puncture Headache After Accidental Dural Puncture
Epidural anesthesia is associated with potential risks and complications, post dural puncture headache (PDPH) one of the most recognized with epidural or spinal anesthesia.
- Trial name
- NCT01448590
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sunnybrook Health Sciences Centre
Pain Management, Cancer Pain
A Pilot Study to Evaluate the Efficacy of ITDD vs. CMM in the Treatment of Pancreatic Cancer Pain
The purpose of this study is to compare efficacy of pain treatment with ITDD to efficacy of pain treatment with CMM in patients with pancreatic cancer pain.
- Trial name
- NCT02578459
- Testing
- Intrathecal Drug Delivery System, Conventional Medical Management
- Where
- United States
- Sponsor
- Flowonix Medical
Obstetric Pain
Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Cesarean delivery is one of the most common surgical procedures, performed at an increasingly high rate. It is associated with intense postoperative pain that may hamper the rehabilitation process and interfere with patient…
- Trial name
- NCT03502642
- Testing
- wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Spinal Anesthesia, intrathecal morphine
- Where
- Lebanon
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Saint-Joseph University
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor
Melphalan in Patients With Neoplastic Meningitis
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or recurrent…
- Conditions
- Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Leukemia, Lymphoma
- Trial name
- NCT00002750
- Testing
- melphalan
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Duke University
Spinal Cord Injury
Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury
This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord…
- Trial name
- NCT01162915
- Testing
- Autologous bone marrow-derived mesenchymal stem cells.
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- TCA Cellular Therapy
Analgesia, Hip Arthropathy
Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty
The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery.
- Conditions
- Analgesia, Hip Arthropathy, Post Operative Pain
- Trial name
- PENGIT (NCT06317870)
- Testing
- Intrathecal morphine, Pericapsular nerve group block (PENG)
- Where
- Switzerland
- Volunteers
- 80 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois