Clinical trials: Intrathecal Drug Delivery
Giant Axonal Neuropathy, Gene Transfer
Intrathecal Administration of scAAV9/JeT-GAN for the Treatment of Giant Axonal Neuropathy
Title: Intrathecal Administration of scAAV9/JeT-GAN for the Treatment of Giant Axonal Neuropathy Background: The Gigaxonin gene lets the body make a protein chemical called Gigaxonin. Nerves need Gigaxonin to work properly.
- Trial name
- NCT02362438
- Testing
- scAAv9/JeT-GAN
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Neoplastic Meningitis
DepoCyt Plus Temozolomide in Patients With Neoplastic Meningitis
Objectives: To determine the safety, tolerability and maximum tolerated dose (MTD) of oral temozolomide using a 7 days on and 7 days off regimen combined with intrathecal liposomal cytarabine (DepoCyt) in patients with neoplastic…
- Trial name
- NCT00515788
- Testing
- DepoCyt, Temozolomide
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- M.D. Anderson Cancer Center
Syringomyelia
Extracellular Vesicles for the Treatment of Syringomyelia
This is a open-label, single-arm, dose escalation phase I clinical trial. The goal of this clinical trial is to evaluate the safety and preliminary efficacy of Intrathecal injection human umbilical cord-derived mesenchymal…
- Trial name
- NCT07295067
- Testing
- Exosomes group
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Xuanwu Hospital, Beijing
Multiple System Atrophy, MSA - Multiple System Atrophy
Study to Evaluate Investigational Allogeneic Cell Therapy Product hOMSC300 for Treatment of Early to Moderate Stage Multiple System Atrophy (MSA)
Purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (hOMSCs) in patients suffering from early to moderate stage Multiple System Atrophy (MSA)
- Trial name
- NCT05698017
- Testing
- hOMSC300
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Cytora Ltd.
Lymphoma, B Cell
Phase II Study of Combined Modality Treatment in Primary Testicular Non-Hodgkin's Lymphoma
The primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-CD20 (Rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in…
- Trial name
- NCT00210379
- Testing
- rituximab, CHOP, intrathecal methotrexate
- Where
- Switzerland
- Volunteers
- 64 people
- Sponsor
- International Extranodal Lymphoma Study Group (IELSG)
NSCLC, Low Dose Radiotherapy
Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
- Conditions
- NSCLC, Low Dose Radiotherapy, PD-1 Inhibitor, Leptomeningeal Metastasis
- Trial name
- NCT06431685
- Testing
- Whole Brain Low Dose Radiotherapy, Pemetrexed, Sintilimab
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Sichuan University
Leptomeningeal Metastases
Intrathecal Pemetrexed for Leptomeningeal Metastasis
Intrathecal chemotherapy is one of the most important treatment modalities for leptomeningeal metastasis of solid tumors. In the previous study(Intrathecal Pemetrexed for Recurrent Leptomeningeal Metastasis From Non-small Cell…
- Trial name
- NCT05289908
- Testing
- Pemetrexed (1), Pemetrexed (2), Folic Acid
- Where
- China
- Volunteers
- 34 people
- Sponsor
- The First Hospital of Jilin University
Phantom Limb Pain, Neuropathic Pain
Intrathecal Dexmedetomidine and Acute Neuropathic Pain After Lower Limb Amputation
This randomized controlled trial evaluated the effect of adding intrathecal dexmedetomidine (10 µg) to hyperbaric bupivacaine (11 mg) for spinal anesthesia in patients undergoing lower limb amputation.
- Conditions
- Phantom Limb Pain, Neuropathic Pain, Lower Limb Amputation
- Trial name
- DEX-RCT (NCT07565662)
- Testing
- Hyperbaric Bupivacaine plus Saline, Hyperbaric Bupivacaine plus Dexmedetomidine
- Where
- Mexico
- Volunteers
- 30 people
- Sponsor
- Universidad Juárez Autónoma de Tabasco
Cerebral Palsy, Spasticity
Dutch National ITB Study in Children With Cerebral Palsy
The objective of this study is to determine the efficacy and safety of treatment with intrathecal baclofen for severe spasticity in children with cerebral palsy.
- Trial name
- NCT00367068
- Testing
- baclofen, intrathecal, infusion pump for intrathecal baclofen, Synchromed, Medtronic
- Where
- Netherlands
- Volunteers
- 18 people
- Sponsor
- Maastricht University
Amyotrophic Lateral Sclerosis Als
Evaluate the Safety and Efficacy of Intrathecal Injection of RJK002 in Patients With Amyotrophic Lateral Sclerosis
The goal of the study aims to evaluate the safety and tolerability of a single intrathecal injection of RJK002 in subjects with amyotrophic lateral sclerosis (ALS), and to determine the recommended Phase II dose (RP2D).
- Trial name
- NCT06493279
- Testing
- RJK002 Intrathecal injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- RJK Biopharma Ltd
Pain, Pain, Postoperative
Effect of Quranic Recitation and Classical Music on Pain Intensity and Interleukin-6 Levels After Lower Limb Orthopedic Surgery With Intrathecal Anesthesia
The goal of this study is to determine the effect of murottal and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia.
- Conditions
- Pain, Pain, Postoperative, Inflammation, Orthopedic Surgical Procedures
- Trial name
- QRCM (NCT06713044)
- Testing
- Murottal Therapy Intervention Name: Murottal (Islamic verse recitation), Classical Music Therapy Intervention Name: Classical Music Listening, Standard Care (in control arm)
- Where
- Indonesia
- Volunteers
- 33 people
- Sponsor
- Universitas Jenderal Soedirman
Hereditary Spastic Paraplegia
A Prospective Cohort Study of ITB Treatment for HSP
The investigators conduct a prospective cohort study to explore the treatment effectiveness of continuous infusion of intrathecal baclofen (ITB) for hereditary spastic paraplegia (HSP) in China, delve into the optimal timing for…
- Trial name
- ITB-HSP (NCT06844734)
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai 6th People's Hospital
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
Analgesic Drug Dependence, Sensory Disorders
Intrathecal Morphine Microdose Method Sensory Changes
Following the retrospective study on the effectiveness of the microdose method of intrathecal morphine therapy, the investigators are interested in measuring the sensory changes at 4 time points during the microdose method.
- Conditions
- Analgesic Drug Dependence, Sensory Disorders, Chronic Pain
- Trial name
- NCT03395275
- Testing
- Quantitative Sensory Tests, surveys
- Volunteers
- healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Leptomeningeal Metastases, Solid Tumors
Combined Intrathecal and Systemic Therapy With Trastuzumab Rezetecan for Leptomeningeal Metastases
This phase II clinical study enrolls patients with leptomeningeal metastases from solid tumors. Participants will receive intrathecal and systemic administration of Trastuzumab Rezetecan.
- Trial name
- ITST-ADC-LM (NCT07833657)
- Testing
- Intrathecal and systemic administration of Trastuzumab Rezetecan
- Where
- China
- Volunteers
- 28 people
- Sponsor
- Jiuda Zhao
Spinal Cord Injury Cervical
Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury
This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2…
- Trial name
- NCT05054803
- Testing
- WJ-MSC (XCEL-UMC-BETA)
- Where
- 2 sites in Spain
- Volunteers
- 18 people
- Sponsor
- Banc de Sang i Teixits
Angelman Syndrome
A Study To Assess Distribution Of RO7248824 In The Central Nervous System Following Single Intrathecal Doses Of [89zr] Labeled RO7248824 In Healthy Male Participants
The aim of Study BP41660 is to quantify the amount and concentration of [89Zr]DFO-RO7248824 in the brain with positron emission tomography (PET) following a single sub-pharmacological dose of RO7248824 and [89Zr]DFO-RO7248824…
- Trial name
- NCT04863794
- Testing
- RO7248824
- Where
- Netherlands
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Malignant Female Reproductive System Neoplasm
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy.
- Trial name
- NCT04258631
- Testing
- Hydromorphone, Laparotomy, Liposomal Bupivacaine
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- Mayo Clinic
Acute Lymphoblastic Leukemia
Liposomal Cytarabine in the Treatment of Central Nervous System Resistant or Relapsed Acute Lymphoblastic Leukemia in Children
The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of…
- Trial name
- CILI (NCT01593488)
- Testing
- liposomal cytarabine
- Where
- 10 sites in Italy
- Volunteers
- 31 people
- Sponsor
- National Cancer Institute, Naples
Post-Dural Puncture Headache
Effect of Intrathecal Neostigmine on Post-dural Puncture Headache.
Intravenous neostigmine was recently reported as an effective treatment for PDPH for parturients after intrathecal (IT) block which is postulated to be through its central effects on CSF secretion and cerebral vascular tone…
- Trial name
- NCT05289323
- Testing
- Neostigmine Methylsulfate, Dextrose 5%/Nacl 0.9% Inj
- Where
- Egypt
- Volunteers
- 722 people
- Sponsor
- Alexandria University