Postherpetic Neuralgia

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo (aluminum hydroxide adjuvant) injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups: treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccine's impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are investigating whether people with herpes zoster, also known as shingles, have a higher risk of blood vessel problems, including stroke, and vascular dementia compared to those without herpes zoster. The study focuses on understanding how exosomes, small particles in the blood, might contribute to these risks by promoting inflammation and clotting, which can affect brain blood flow. This observational research aims to clarify how herpes zoster could lead to vascular dementia and stroke over time. Participants are divided into two groups: those with untreated acute herpes zoster and those without herpes zoster. The herpes zoster group will have six visits over a year, starting from the first day of rash appearance and continuing at 7 days, 1 month, 3 months, 6 months, and 12 months after. The control group will have a single visit. No study medications or devices are given; all participants receive standard care. During the visits, the study collects data and blood samples to analyze exosome content and how it affects cells involved in blood vessel function. Researchers will measure proteins and genetic material in exosomes linked to vascular damage and monitor inflammatory responses. They will also assess platelet activation, blood vessel cell health, and the risk of stroke or vascular events. The primary goal is to understand the mechanisms behind increased vascular dementia risk in herpes zoster patients over a 12-month period.

Researchers are evaluating the effect of the recombinant zoster vaccine on the risk of developing new dementia diagnoses among adults aged 76 years or older living in Finland. This phase IV pragmatic trial aims to assess whether receiving this vaccine influences the incidence of dementia, including Alzheimer's disease, over a long follow-up period. Participants will be randomly assigned to receive either the vaccine or a placebo. Participants in the vaccine group receive two doses of the recombinant zoster vaccine: the first dose on Day 1 and the second dose between 2 and 6 months later, following the approved dosing schedule. Those in the placebo group receive two doses of placebo injections on the same schedule. The study is randomized, placebo-controlled, and observer-blind to compare outcomes between these two groups. During the study, participants will be followed for up to 10 years after their first dose to monitor for new dementia diagnoses, death, or loss to follow-up. Researchers will use health register data to assess outcomes including new diagnoses of dementia and Alzheimer's disease. Safety monitoring includes exclusion of severely immunocompromised individuals and those living in nursing facilities. The total participation duration allows long-term observation of vaccine effects on dementia risk.

Researchers are evaluating the safety and immune response of two doses of a recombinant herpes zoster vaccine (RHZV) in healthy adults aged 40 and older. The study includes two parts: Substudy A (Phase I) and Substudy B (Phase II). It aims to assess different vaccine candidates, including dose levels, compared with the approved shingles vaccine and controls, to better understand their effects in various age groups. In Substudy A, participants aged 40-49 and 50+ will receive one of two RHZV candidates, the approved shingles vaccine, adjuvant controls, or saline via intramuscular injection on days 0 and 60. This phase includes a 12-month safety follow-up, totaling about 14 months of involvement. Substudy B includes age groups 40-49, 50-69, and 70+, using similar vaccination schedules and treatments. Some groups will continue to be monitored for up to 2 years to study the persistence of immunity. Participants will undergo regular safety assessments including monitoring immediate, solicited, unsolicited, and serious adverse events after vaccination. Researchers will measure antibody levels and immune response at multiple timepoints up to two years, using blood tests for specific antibodies. Study visits will include vaccinations, follow-ups, and immune response evaluations, helping to understand the vaccine's safety and the body's lasting immune reaction.

Researchers are evaluating the reactogenicity, safety, and immune response of two doses of PED-HZ/su, GlaxoSmithKline's vaccine candidate, for preventing Herpes Zoster in immunocompromised children aged 1 to 17 years who have had a kidney transplant. This Phase 1/2 study focuses on pediatric renal transplant recipients to understand how the vaccine performs in this vulnerable group. Participants are divided by age and treatment into four groups: children aged 12 to 17 receiving the vaccine, similar-aged children receiving standard care without the vaccine, children aged 1 to 11 receiving the vaccine, and the youngest group receiving standard care. Vaccinated groups receive two intramuscular doses of PED-HZ/su in the deltoid muscle on day 1 and one month later. The younger age group enrollment is staggered, starting after safety data from the older group is reviewed. During the study, participants are monitored closely for local and general adverse events within seven days after each vaccination, as well as unsolicited adverse events and serious safety concerns up to two months post-vaccination. Researchers measure antibody levels one month after the second dose to assess immune response. Follow-up continues up to 13 months to track serious events, kidney transplant rejection, and occurrence of Herpes Zoster. The study includes careful assessment of seizures and other potential side effects related to the vaccine.

This research aims to understand neuropathic pain in children and adolescents who had limb amputations during childhood. It focuses on two types of neuropathic pain: phantom limb pain and residual limb pain. The study also looks at quality of life and functional independence in these young patients, exploring links between pain, autonomy, quality of life, and age when the amputation occurred. This observational study uses both past medical records and questionnaires to gather information without changing patient care. Participants are children and teens aged 5 to 18 years who had limb amputations before age 15 for girls and 16 for boys. The study collects data from medical records and standardized questionnaires during routine follow-up visits at a specialized pediatric limb anomaly center. There is no treatment or intervention; data collection happens at a single time point to assess neuropathic pain and its effects. During the study, participants provide information through questionnaires about neuropathic pain, quality of life, and functional abilities. Researchers also review medical records for relevant history. The main measure is the presence of neuropathic pain after amputation. Other outcomes include types of pain, health-related quality of life, locomotor and upper limb function, and correlations between pain scores and age at amputation. Participation involves only one visit during routine care, with no extra procedures or treatments.

This research aims to evaluate the effectiveness of a Capsaicin 8% cutaneous patch in children aged 12 to 17 years who have local chronic neuropathic pain lasting more than two months after trauma or surgery. The study involves children with persistent neuropathic pain despite oral treatment or those with less severe pain without oral treatment. It is a multicenter randomized controlled superiority trial comparing the capsaicin patch to a hydrocolloid dressing as a control. Participants are randomly assigned to receive either the Capsaicin 8% patch, which contains 179 mg of capsaicin and measures 14 cm by 20 cm, or a hydrocolloid dressing measuring 15 cm by 15 cm. The initial treatment is applied at the start of the study, with a second application three months later if needed. The patches are applied to intact, dry, non-irritated skin for 30 minutes on the feet or 60 minutes on other body areas. Children will be monitored through monthly clinical consultations for four months after the first patch application to assess treatment effectiveness and safety. Tolerance is checked during each application and by follow-up phone calls until cold sensation subsides. Researchers will measure changes in neuropathic pain using the Neuropathic Pain Symptom Inventory and evaluate functional disability, vital signs, skin condition, pain related to treatment, use of pain medication, and adverse events throughout the study.

This research aims to understand the key cells and molecules involved in neuropathic pain treated with spinal cord stimulation (SCS). It focuses on measuring inflammatory mediators and signaling molecules like IL-1β, IL-6, IL-17, IL-33, BDNF, VEGF, and GABA in the blood and cerebrospinal fluid (CSF) of patients undergoing SCS. The study seeks to clarify how SCS works, explore differences in responses to stimulation types, and improve personalized neuromodulation strategies for neuropathic pain conditions such as post-surgical pain syndrome and complex regional pain syndrome. Patients will undergo SCS, where electrodes are placed on the spinal cord dura mater followed by trial stimulation lasting 2-3 weeks. If effective, a permanent implantable pulse generator (IPG) is implanted. Blood samples are collected before surgery and 2-3 weeks after, while CSF samples are taken during both the first and second procedures. Patients may be grouped based on stimulation parameters such as tonic or burst stimulation, with some possibly in a sham group. The collected samples will be analyzed for inflammatory markers using ELISA techniques. Throughout the study, participants will have their pain levels assessed using the Visual Analogue Scale (VAS) and quality of life measured by the Oswestry Disability Index (ODI) before and after trial stimulation. Neurological exams and medication logs will also be maintained. Researchers will monitor changes in inflammatory markers and clinical outcomes to evaluate the effects of SCS. The study includes ongoing safety monitoring and personalized adjustment of stimulation parameters after sample collection, with total participation spanning the trial stimulation period and follow-up assessments.

Researchers are studying how daily changes in mood, pain, and activity relate to acute and chronic pain using a smartphone app called SOMA. The study includes people with acute pain, chronic pain, and healthy controls. A smaller sub-study focuses on patients with chronic low back pain, failed back surgery syndrome, or fibromyalgia, using EEG testing to explore brain and behavior patterns that might predict treatment responses. Participants will use the SOMA app daily for four months to track their symptoms and activities. Those in the sub-study will also attend an in-person EEG session to perform specific tasks before starting app use. Data collected will help identify patterns linked to pain transition, recovery, or flare-ups. The study also monitors app engagement and symptom dynamics over up to 12 months. During the study, participants will report pain, mood, and activity daily through the app. Researchers will analyze these reports alongside baseline and follow-up EEG and behavioral tests. Outcomes include measuring the likelihood of acute pain becoming chronic and understanding mood and pain interactions. Participants' progress and app usage will be observed over time to assess feasibility and treatment effects.