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NCT02362438
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. Giant Axonal Neuropathy (GAN) causes a shortage of functional Gigaxonin. Nerves stop working normally in people with GAN. This causes problems with walking and sometimes with eating, breathing, and many other activities. GAN has no cure. Over time, GAN can shorten a person s life. Researchers want to see if a gene transfer treatment may help people with GAN. Objectives: \- To see if a gene transfer is safe and shows potential to help people with GAN. Eligibility: \- People age 3 and older with GAN. Design: * For 1 month following gene transfer participants must live full-time within 100 miles of the NIH. * Participants will be screened by phone and in person. They will take many tests. Some are listed below. Their medical records will be reviewed. Their caregivers may be contacted. * Participants will have a total of about 27 visits, weekly, monthly, and then yearly over 15 years. They will include many of the tests below. * Physical and nervous system exams. * Blood, urine, and stool samples. * Nerve, lung, heart, and eye tests. * Questionnaires. * MRI scans, nerve biopsies, and spinal taps. Participants will be sedated for some tests. * Speech, memory, muscle, and mobility tests. * Skin biopsy (small sample removed). * Participants will take many medicines. Some require intravenous lines. * Participants will get the gene transfer through an injection by spinal tap into their cerebrospinal fluid, which flows around the brain and spinal cord. The genes are packed in a modified virus that carries the genes to cells in their body. Participants safety is not guaranteed.
NCT06376240
Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation.
NCT06859099
This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.
NCT07525882
This observational cross-sectional study aims to investigate the effects of glycemic control and clinical parameters on tibial nerve conduction latency in individuals with diabetic peripheral neuropathy. Adults aged 45 to 76 years with diabetic peripheral neuropathy will be evaluated at a neurology and clinical neurophysiology clinic. Data collection will include demographic and clinical characteristics, diabetes type and duration, fasting blood glucose, and HbA1c values obtained from routine clinical records. Participants will also be assessed using the Michigan Neuropathy Screening Instrument (MNSI), including both the questionnaire and physical examination components. Nerve conduction studies will be performed using standard electromyography procedures, and tibial nerve conduction latency will be recorded. The study will examine the relationship between tibial nerve conduction latency and glycemic control parameters, neuropathy screening scores, and diabetes duration. The findings may help improve early identification and clinical evaluation of diabetic peripheral neuropathy.
NCT06614322
The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy. The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC). This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks. Participants will: * Undergo a quantitative sensory testing (QST) exam. * Provide a blood sample. * Complete questionnaires on the computer. * Take the study drug as instructed.
NCT07543991
Giant axonal neuropathy (GAN) is a rare pediatric disorder caused by autosomal recessive mutations in the GAN gene. GAN is a multisystem, neurodegenerative disorder affecting the peripheral nervous system (PNS), central nervous system (CNS) and autonomic nervous system (ANS). GAN is a fatal disease with many patients not surviving past early adulthood due to aspiration pneumonia and pulmonary complications. Currently, there are no approved drugs or other therapies for the treatment of GAN; and only supportive care therapies exist, leaving an unmet medical need to treat this rare, progressive, and ultimately fatal neurodegenerative disease. The drug used in this study (scAAV9/JeT-GAN) has been studied in a previous gene therapy clinical trial by which the drug was administered as a single injection into the spinal canal (intrathecal \[IT\] administration) to treat the symptoms associated with the CNS and PNS neurodegeneration; however, this administration method did not address the symptoms associated with neurodegeneration of the ANS. To treat the symptoms associated with ANS, this study has been designed to evaluate the safety and tolerability of a single dose of scAAV9/JeT-GAN administered directly into the left vagus nerve (intraneurally) in participants who have previously received scAAV9/JeT-GAN administered intrathecally. This study involves the use of an investigational drug called scAAV9/JeT-GAN "Investigational" means that the drug has not been approved by the U.S. Food \& Drug Administration (FDA) for the treatment of GAN and the progression of neurodegeneration to the CNS, PNS and ANS. This is the first study in humans to administer the drug directly into the left vagus nerve. We want to find out what effects, good and/or bad, scAAV9/JeT-GAN has when administered directly into the vagus nerve. The safety of intrathecal (IT) administration of scAAV9/JeT-GAN has been established in a prior research study; however, the people in this study will be the first people to receive the drug intraneurally. As a result, information about the safety and effectiveness of the route of administration is incomplete and all of the possible side effects are not yet known.
NCT06858579
The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
NCT06290141
The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.
NCT07260656
The purpose of this research is to assess whether the use of a topical cream with an active ingredient can reduce the amount of foot pain experienced in participants who have been diagnosed with Diabetic Peripheral Neuropathy (DPN) with minimal side effects or discomfort from use.
NCT07027111
The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new drug that is being developed for treating patients with CIDP. NVG-2089 is designed to mimic the effects of a protein called IVIg. NVG-2089 is designed to potentially help the immune system by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports how the immune system works.
NCT06637072
This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
NCT07369297
Accurate evaluation of dental pulp health is essential to avoid unnecessary endodontic treatments. In routine dental practice, pulp sensibility is commonly assessed using electric pulp testing and thermal (cold) testing. However, these tests depend on patient perception and may be influenced by various factors such as systemic diseases, nerve damage, anxiety, trauma, or medication use. Diabetic polyneuropathy is a common complication of diabetes mellitus and may alter peripheral nerve function, potentially affecting dental pulp sensibility test responses. This clinical study aims to evaluate how the severity of diabetic polyneuropathy influences dental pulp sensibility responses and masseter inhibitory reflex (MIR) parameters. The MIR is an objective neurophysiological reflex that allows quantitative assessment of trigeminal nerve function. In this study, individuals with mild diabetic polyneuropathy, severe diabetic polyneuropathy, and healthy controls will be evaluated. All participants will undergo electric pulp testing, cold testing, and MIR measurements using standardized protocols. The primary hypothesis of this study is that increasing severity of diabetic polyneuropathy leads to reduced dental pulp sensibility responses and altered MIR parameters compared to healthy individuals. It is further hypothesized that conventional pulp sensibility tests may produce false-negative results in patients with advanced neuropathy. The findings of this study are expected to contribute to more accurate endodontic diagnosis and improved understanding of orofacial neurophysiological changes in diabetic patients.
NCT07072468
Peripheral neuropathy is a disorder caused by damage to the peripheral nerves. Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of certain chemotherapy drugs, such as platinum-based compounds, taxanes, and vinca alkaloids, which can damage nerve fibres by disrupting their structure and function. At present, relief of neuropathic pain in CIPN is limited, and existing therapies providing only modest and variable efficacy across patients. This is a study of VMD-3866 gel (the study medicine which is non-opioid, non-NSAID), an experimental new topical medicine for treating pain caused by CIPN. The goal of this study is to assess if the study medicine improves pain symptoms in patients with CIPN, and to find out the side effects of the study medicine if any. The study medicine will work by selectively blocking a specific sub-type of proteins (called T-type calcium channels) in the nerves under the skin which will lower the activity of the nerves and therefore reduce pain. It is a topical gel, meaning that it is applied to the skin, and its novel gel formulation limits that only little amount of study medicine may enter the blood and none enters the brain. This means it's unlikely to be addictive and it's unlikely to have any impact on participant current medications. Researchers will compare study medicine to a matching placebo (a look-alike gel that contains no drug) to see if VMD-3866 gel works to management of pain caused by CIPN.
NCT07409987
This research was conducted to evaluate the effect of electrostimulation and compression applications on the severity, number, and pain levels of neuropathy symptoms and the quality of life of patients with metastatic gastrointestinal cancer receiving oxaliplatin-based treatment in the management of chemotherapy-induced peripheral neuropathy. The study population consisted of patients with gastrointestinal cancer between 2025-2026 . Data collection tools were administered to patients who met the inclusion criteria and developed chemotherapy-induced peripheral neuropathy. Patients were then stratified by age and gender and assigned to "control group, electrostimulation group, compression group, and electrostimulation+compression group" using block randomization. Statistical power analysis determined the total number of participants in the study as 140 patients, with 35 patients in each group. Patients in the control group benefited from the clinic's standard procedures and received no intervention
NCT07480330
Diabetic polyneuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and is characterized by peripheral nerve damage caused by long-term hyperglycemia. Progressive sensory loss and impairment of proprioception may lead to balance disturbances, gait instability, and an increased risk of falls. Neurofilament Light Chain (NfL) has emerged as a potential biomarker of neuroaxonal injury in several neurological disorders. The aim of this observational cross-sectional study is to investigate the relationship between serum Neurofilament Light Chain (NfL) levels and neuropathy severity, balance performance, and fall risk in patients with diabetic polyneuropathy. Neuropathy severity will be evaluated using the Michigan Neuropathy Screening Instrument (MNSI) and electrophysiological findings, while balance performance and fall risk will be assessed using the Berg Balance Scale and the Falls Efficacy Scale-International (FES-I).
NCT06405542
The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are: * Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN? * Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)? Researchers will provide all participants with the exercise-based intervention. Participants will: * Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention * Complete a 10-week remote, individualized exercise program * Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention * Wear a FitBit throughout the study to track physical activity and promote behaviour change
NCT06742190
The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months. More information can be found here: https://clinicaltrials.argenx.com/empassion
NCT06752356
The current study is being conducted to assess the efficacy and safety of KIg10 (Intravenous Human Immune globulin 10%) at two different dosages as maintenance therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) following 21 weeks of treatment.
NCT07016971
The goal of this clinical trial is to learn if a commercially available cannabigerol (CBG)/cannabidiol (CBD) oil is safe, feasible to use, and can help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in adults who have completed platinum-based chemotherapy for gastrointestinal cancers. The main questions it aims to answer are: Is CBG/CBD oil safe and well-tolerated over a 12-week treatment period? Can participants with CIPN use CBG/CBD oil consistently as part of their care? Does CBG/CBD oil help reduce pain, numbness, or other symptoms of CIPN? Participants will: Take CBG/CBD oil under the tongue (sublingually) twice daily for 12 weeks Complete regular symptom assessments and functional tests during study visits Provide blood samples for cannabinoid and metabolite level testing
NCT07264426
The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the "treatment journey" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod. As this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care. Each participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.