Clinical trials: Intrathecal Drug Delivery
EGFR-TKI-resistant Non-small Cell Lung Cancer With Leptomeningeal Metastasis
Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer
This study is a Phase I, single-arm, single-center, dose-escalation clinical trial designed to investigate the safety and efficacy of intrathecal injection of sacituzumab tirumotecan (sac-TMT) in patients with EGFR…
- Trial name
- NCT07702305
- Testing
- Sacituzumab tirumotecan
- Volunteers
- 15 people
- Sponsor
- Henan Cancer Hospital
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Intrathecal Ziconotide in Chemotherapy Induced Peripheral Neuropathy
The purpose of this observational, data collection, research is to evaluate if ziconotide, a commercially approved medication given by a FDA cleared intrathecal pump, for chronic pain is effective in the treatment of…
- Trial name
- NCT07499882
- Testing
- Ziconotide
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Christian Hospital Northeast Northwest
Huntington's Disease
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single or repeat doses of ALN-HTT02.
- Trial name
- NCT06585449
- Testing
- ALN-HTT02
- Where
- 19 sites in Canada, Germany and 1 more
- Volunteers
- 66 people
- Sponsor
- Alnylam Pharmaceuticals
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
Amyotrophic Lateral Sclerosis (ALS)
An IIT Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Single Intrathecal Injection of SNUG01 in Patients with Amyotrophic Lateral Sclerosis
This is a multicenter, open-label, single-arm investigator-initiated clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SNUG01 in patients with Amyotrophic Lateral Sclerosis (ALS).
- Trial name
- ALS (NCT06645197)
- Testing
- SNUG01
- Where
- 5 sites in China
- Volunteers
- 7 people
- Sponsor
- Peking University Third Hospital
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
Postoperative Pain, Analgesia
Intrathecal Morphine Versus Epidural Analgesia for Laparoscopic Colon Surgery
Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing…
- Conditions
- Postoperative Pain, Analgesia, Colorectal Cancer, Surgery
- Trial name
- NCT06881563
- Testing
- Intrathecal Morphine, Epidural Analgesia
- Where
- Croatia
- Volunteers
- 98 people
- Sponsor
- Meri Mirceta
Leptomeningeal Metastasis, Lung Neoplasms, Non-Small Cell Lung Cancer
Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metastatic NSCLC: A Phase II Study
The goal of this clinical trial is to explore the efficacy and safety of double-dose third-generation EGFR-TKI combined with bevacizumab and intrathecal chemotherapy in treating advanced non-small cell lung cancer (NSCLC)…
- Trial name
- NCT07398599
- Testing
- a combined regimen consisting of double-dose third-generation EGFR-TKI, bevacizumab, and intrathecal chemotherapy in patients
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Amyotrophic Lateral Sclerosis
A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)
The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to <80 years of age with ALS who carry superoxide…
- Trial name
- ARMOR (NCT07290062)
- Testing
- INS1202
- Where
- 7 sites in United States
- Volunteers
- 23 people
- Sponsor
- Insmed Gene Therapy LLC
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
Chronic Pain
The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery
The purpose of this observational registry is to collect a continuum of meaningful clinical data on the ARCHIMEDES implantable pump in pain management
- Trial name
- NCT00196053
- Testing
- Archimedes Constant Flow Implantable Pump
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 55 people
- Sponsor
- Codman & Shurtleff
Postoperative Pain, Analgesia
Evaluation of Dexketoprofen in Total Knee Arthroplasty
Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain.
- Trial name
- NCT04161690
- Testing
- Dexketoprofen Trometamol, Ropivacaine Hydrochloride 7.5 MG/ML
- Where
- Greece
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- KAT General Hospital
Gastric Cancer
Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-
The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia…
- Trial name
- NCT01234272
- Testing
- morphine, Ropivacaine
- Where
- South Korea
- Volunteers
- 59 people
- Sponsor
- Yonsei University
Multiple Sclerosis
Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis
The study is an open-label, phase I clinical trial designed to evaluate the safety and tolerability of intrathecal administration of autologous mesenchymal stem cell-derived neural progenitor cells (MSC-NP) in patients with…
- Trial name
- NCT01933802
- Testing
- intrathecal administration of autologous MSC-NP
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Tisch Multiple Sclerosis Research Center of New York
Solid Tumour Neoplastic Meningitis, Brain Metastases
Study to Demonstrate the Safety of WBR Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyte®) Versus Intrathecal Liposomal Cytarabine (DepoCyte®) Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastasis.
The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with leptomeningeal metastases.
- Trial name
- NCT00854867
- Testing
- Whole Brain Radio Therapy (WBRT) with sequential Depocyte, Whole brain radiotherapy (WBRT) with concomitant Depocyte
- Where
- 7 sites in Austria, Germany
- Volunteers
- 18 people
- Sponsor
- Mundipharma Research Limited
Meningitis, Neoplasms
Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine
Subject's are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges (tissues that cover the brain and spinal cord).
- Trial name
- NCT00074607
- Testing
- Gemcitabine
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Baylor College of Medicine
Leptomeningeal Metastasis, NSCLC
Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases
Leptomeningeal metastases (LM) are a relatively rare site of metastasis in advanced non-small cell lung cancer (NSCLC), and LM patients have a poor prognosis.
- Conditions
- Leptomeningeal Metastasis, NSCLC, Intrathecal Chemotherapy, Tyrosine Kinase Inhibitor
- Trial name
- NCT07092202
- Testing
- Firmonertinib, Intrathecal injection of pemetrexed
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Acral Lentiginous Melanoma, Central Nervous System Melanoma
Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease
This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease.
- Conditions
- Acral Lentiginous Melanoma, Central Nervous System Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Leptomeningeal Neoplasm
- Trial name
- NCT03025256
- Testing
- Biospecimen Collection, Computed Tomography, Lumbar Puncture
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- M.D. Anderson Cancer Center
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.