Botulinum Toxin

Researchers are studying the effects of Huperzine A Injection on reducing postoperative delirium in elderly patients aged 75 and older who are undergoing non-cardiac surgery. This randomized, double-blinded, placebo-controlled trial aims to observe how this treatment may influence the occurrence of delirium after surgery in this older population. Participants will be randomly assigned to receive either Huperzine A Injection or a placebo of 0.9% Sodium Chloride Injection during their non-cardiac surgical procedure. The study includes patients with an anesthesia grade of III to IV and an estimated operation time of at least 2 hours. The treatments will be administered under controlled conditions to carefully assess their effects on postoperative delirium. During the study, participants will be monitored for delirium incidence within 7 days after surgery, with additional evaluations at 24, 48, and 72 hours post-operation. Researchers will also assess the type, severity, and duration of delirium, length of hospital stay, economic costs, complications, mortality rates, and cognitive function using the Mini-mental State Examination and EuroQol scale. Follow-up assessments will continue up to 2 months after surgery, with some evaluations occurring around 30 days after discharge.

Researchers are evaluating Corabotase also known as IPN10200 to assess its effectiveness and safety compared to a placebo for improving the appearance of moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. These lines can become more noticeable with age or repeated facial expressions and may affect a persons confidence. This Phase III, multicenter, randomized, double-blind study aims to measure treatment response and participant satisfaction. Participants will be randomly assigned to receive a single injection of either Corabotase or placebo into the muscles between the eyebrows during one treatment visit on Day 1. The study includes a screening period up to 20 days to determine eligibility, followed by the treatment day and a 52-week follow-up period. During follow-up, participants will have regular visits and one phone call to monitor their health and treatment effects. Throughout the study, participants will undergo physical exams, blood tests, heart electrical activity recordings ECG, clinical evaluations, questionnaires, and keep a diary. The research team will measure improvement in glabellar lines at various time points up to one year, along with participant satisfaction and safety events. Participants may withdraw from the study at any time, and the total participation lasts up to 55 weeks.

Researchers are evaluating the effectiveness and safety of Corabotase IPN10200 in adults with moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows that may affect appearance and confidence. This Phase III study compares a single dose of Corabotase to a placebo in a double-blind phase, followed by an open-label phase to assess repeat doses over time. Participants will receive injections of Corabotase or placebo into selected facial muscles. The study includes a screening period of up to 20 days, a treatment period with up to four treatment cycles where participants may receive Corabotase or placebo in the double-blind phase and Corabotase in the open-label phase, and a follow-up period lasting 24 weeks after the last injection. Multiple visits occur during the first month of treatment, followed by monthly visits. During the study, participants will have health assessments including blood tests, physical exams, ECGs, questionnaires, and diaries. Researchers will measure treatment response at week 4 and monitor safety and satisfaction through week 104. Total participation lasts up to 107 weeks, and participants may withdraw at any time.

This research focuses on patients experiencing stiff knee gait SKG, a condition caused by spastic muscle complications in the leg that can result from stroke, brain injury, spinal cord damage, or multiple sclerosis. SKG affects the mobility of the knee joint, leading to stiffness that hampers walking ability. The study aims to observe and compare balance and risk of falls before and after treatment with botulinum toxin injections in the rectus femoris muscle, which is a current standard treatment to reduce muscle spasticity in these patients. Participants will receive botulinum toxin injections targeted to the rectus femoris muscle. The study is observational and will evaluate the effects of these injections on balance and walking ability without altering standard care. Functional clinical tests such as the Time Up and Go test, Berg Balance Scale, Stair Climb and Descent Time test, and a questionnaire about the number of falls will be used to assess participants before and four weeks after the injections. Throughout the study, participants will undergo these clinical tests to measure static and dynamic balance and walking function. Researchers will specifically focus on the Time Up and Go test as the primary outcome four weeks after treatment. Secondary outcomes include balance scale scores, stair climbing times, and fall frequency. The study will also monitor safety and compliance. The total study duration for each participant is at least four weeks from the inclusion visit to the post-injection evaluation.

Researchers are evaluating the use of prophylactic antibiotics before intradetrusor injection of onabotulinumtoxinA in patients with overactive bladder OAB who are not showing symptoms of urinary tract infection UTI. This treatment is FDA approved and used when behavioral and oral medication therapies have not controlled OAB symptoms. Since UTIs are a common side effect of this injection and antibiotics are commonly given beforehand, this study aims to determine if antibiotics are necessary for patients without UTI symptoms and with negative urinalysis, addressing concerns about antibiotic overuse and resistance. The study compares two groups one receiving a single dose of prophylactic antibiotics before the injection, which is the current standard of care, and another receiving no antibiotics prior to the cystoscopic injection of onabotulinumtoxinA. The choice of antibiotic depends on prior urine culture results, allergies, and medical conditions. The trial is randomized and monitors patients for differences in post-procedure symptomatic UTI rates. Participants will be assessed for symptomatic UTI within 14 days after the injection. Secondary measures include improvements in OAB symptoms and rates of side effects like painful urination, bloody urine, and urinary retention over 14 to 30 days. The study involves urine tests, symptom questionnaires, and monitoring for adverse events. The total duration of participation is based on follow-up visits within the first month after treatment to evaluate safety and treatment outcomes.

Researchers are investigating how subcutaneous injections of botulinum toxin A affect healing of wounds caused by lower extremity ischemia, a condition where blood flow to the legs is reduced or blocked. This condition often affects elderly patients or those with diabetes, causing chronic wounds or ulcers due to narrowed or blocked blood vessels. The study focuses on patients with wounds on their feet where blood circulation relies mainly on collateral vessels.

Researchers are evaluating the effectiveness, safety, and immune response of single and repeated injections of Eveotox, a recombinant botulinum toxin type A, for treating moderate to severe glabellar lines frown lines. This Phase 3 study includes two parts Part 1 is a randomized, double-blind, controlled trial comparing Eveotox with Botox and placebo Part 2 is an open-label study assessing repeated Eveotox injections. Participants in Part 1 receive one injection cycle of either Eveotox 20 Units, Botox 20 Units, or placebo in a double-blind manner. Following this, all participants may receive up to three open-label cycles of Eveotox injections 20 Units each. The injections are administered in five divided doses into the glabellar area. Throughout the study, participants will attend scheduled visits to monitor treatment effects and safety. Researchers will assess the severity of glabellar lines using both investigator and patient scales within 4 weeks after treatment, with additional safety and efficacy evaluations continuing up to 52 weeks. The study aims to fully assess the treatments impact and immune response over time.

This research aims to explore the therapeutic effect of Botulinum toxin Botox injections in patients with trismus, a common side effect of radiation therapy for head and neck cancer. The study evaluates how Botox injections combined with oral rehabilitation exercises may help reduce muscle tension and spasms in the masticatory muscles, potentially improving mouth opening, quality of life, trismus condition, and pain. Participants will be randomly assigned to receive either echo-guided Botox injections or echo-guided normal saline injections into the masticatory muscles, including the medial pterygoid muscle. The study uses a triple-masked design to compare these treatments. The treatment period lasts up to six months, during which patients also perform oral rehabilitation exercises to support muscle function. During the trial, participants maximal mouth opening will be measured from enrollment through the six-month treatment period. Researchers will also assess quality of life, trismus symptoms, and pain levels. The study monitors the patients health conditions to ensure stability and safety throughout the treatment. Overall participation lasts at least six months, with close observation of treatment effects and any side effects.

This research aims to compare the effectiveness and safety of all commercially available Botulinum Neurotoxin Type A BoNT-A products in treating glabellar rhytides, commonly known as frown lines. It is a multicenter, triple-blind, randomized controlled trial enrolling women aged 18 years or older with moderate to severe frown lines. The study addresses which BoNT-A product provides the longest lasting effect and compares safety profiles, filling gaps in current knowledge. Participants will receive injections of one of five different BoNT-A formulations, including Botox, Xeomin, Dysport at two dosing levels, and Jeuveau. Each treatment involves specific unit doses injected into targeted facial muscles. The study includes baseline and follow-up assessments over 16 weeks, with weekly smartphone photographs documenting changes. Questionnaires on satisfaction, quality of life, and symptoms will be completed at the start and end of the study. During the study, participants will be closely monitored through clinical assessments and secure digital submissions of weekly photos. Researchers will evaluate the duration of treatment efficacy using standardized scales and analyze safety by tracking side effects. Secondary outcomes include quality of life, social functioning, and symptom changes over several weeks. The total participation period extends up to 16 weeks with active follow-up to assess treatment effects and participant experiences.

Researchers are evaluating the use of botulinum toxin injections as a potential alternative treatment for thumb carpometacarpal CMC osteoarthritis, a common cause of thumb joint pain. This study compares botulinum toxin injections to the standard corticosteroid injections, which are commonly used but have limited effectiveness and notable side effects. The trial aims to gather information on the safety and effectiveness of botulinum toxin for reducing thumb joint pain and arthritis symptoms. Participants will be randomly assigned to receive either the standard corticosteroid injection or a botulinum toxin injection directly into the thumb CMC joint. The botulinum toxin works differently from steroids by temporarily affecting nerve signals and reducing pain mediators. The study includes follow-up at several time points to assess the effects of the injections over time. Throughout the study, participants will have their thumb pain measured using a visual analog scale VAS at 2 weeks, 1 month, 6 months, and 1 year after injection. In addition, grip strength and thumb range of motion will be evaluated at these same visits. The study involves monitoring for safety and effectiveness over this one-year period to better understand how botulinum toxin may help manage thumb CMC osteoarthritis pain.