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 the safety and effectiveness of NT 201, a type of botulinum toxin A, compared with a placebo in adults who have moderate to severe platysma prominence, which refers to noticeable bands in the neck area. This Phase 3 study aims to understand how well NT 201 works and how safe it is for these participants. The study is sponsored by Merz Aesthetics GmbH and will be conducted in Europe. Participants will be randomly assigned to receive either a single injection of NT 201 or a matching placebo injection in the main study period (MP) on Day 1. After this period, those who received NT 201 can enter an open-label extension period (OLEX) where they will receive another injection of NT 201 on Day 1 of that phase. The study involves a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during the main period. During the study, participants will be assessed using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) to measure improvement in platysma prominence at various time points, including Week 2 and up to Week 17 in the main period. Both investigator and participant assessments will be used to evaluate the degree of improvement. Satisfaction questionnaires and global aesthetic improvement scales will also be used to measure participant satisfaction and aesthetic changes. Safety and efficacy will be closely monitored throughout the study, which lasts through the main and extension periods.

Researchers are evaluating the effectiveness and safety of IPN10200 compared to a placebo in 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 person's appearance and confidence. This is a Phase III, multicenter, randomized, placebo-controlled study involving adult participants. Participants will receive a single injection of either IPN10200 or placebo into selected muscles on the first day of treatment. The study includes three periods: a screening period lasting up to 20 days to determine eligibility, a treatment period on Day 1 with the injection, and a follow-up period lasting 52 weeks to monitor participants' health. During follow-up, participants will have regular visits to the study center and one telephone call visit. Throughout the study, participants will undergo health assessments including blood sampling, physical examinations, clinical evaluations, and electrocardiograms (ECG). They will also complete questionnaires and keep a diary to track their progress. The primary outcome is the percentage of participants responding to treatment from baseline to week 4. Safety and satisfaction measures will be monitored up to one year. Participants may withdraw consent at any time, and the total study duration for each participant is up to 55 weeks.

Researchers are evaluating the effectiveness and safety of IPN10200, a treatment for moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. The study focuses on adult participants and includes both a double-blind phase comparing a single dose of IPN10200 to placebo, and an open-label phase assessing repeat doses over time. The study aims to understand how well IPN10200 works and how safe it is for improving these facial lines. Participants may receive IPN10200 or placebo injections into specific muscles in the glabellar region during the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase may receive IPN10200 for up to four treatment cycles. The study includes a screening period of up to 20 days, a treatment period with multiple visits in the first month followed by monthly visits, and a 24-week follow-up after the last injection to monitor health. Throughout the study, participants will have health assessments including blood tests, physical exams, clinical evaluations, and ECGs. They will also complete questionnaires and keep diaries. Researchers will measure treatment response at specific weeks using scales that evaluate wrinkle severity and participant satisfaction. Safety and long-term effects including antibody development and adverse events will be closely monitored. Each participant may be involved for up to 107 weeks and can withdraw at any time.

Researchers are evaluating the safety, effectiveness, and immune response of YY003, a recombinant botulinum neurotoxin injection, in adults with moderate to severe glabellar lines, which are wrinkles between the eyebrows. This randomized, double-blind, vehicle-controlled study includes 174 participants and aims to compare YY003 to a placebo treatment to see if it improves the appearance of these lines. Participants will receive a single intramuscular injection of either a low dose or high dose of YY003 or a vehicle control, administered over five injection sites on Day 1. Each injection delivers a total volume of 0.25 ml, divided as 0.05 ml per site. The study is conducted in two parts and is designed to carefully monitor the effects and safety of the treatment. During the study, participants will be followed for at least 4 weeks after treatment to track any adverse events, including serious or special interest events. Researchers will assess the improvement in wrinkle severity based on both investigator and participant evaluations at maximum frown four weeks post-treatment. Additional monitoring for anti-drug antibodies will occur within 12 weeks. Participants must be able to comply with study requirements and attend scheduled visits throughout the trial.

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 efficacy, safety, and immune response of Eveotox, a recombinant botulinum toxin type A, for treating moderate to severe glabellar 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. The study aims to understand how well Eveotox works and its safety profile in this population. Participants receive one of three treatments during the first cycle: Eveotox (20 Units divided into five injections), Botox (20 Units), or placebo, all administered into the glabellar area in a double-blind fashion. After the initial cycle, participants may receive up to three additional open-label cycles of Eveotox. This dosing and schedule allows comparison of single and repeated treatments. During the study, participants will attend scheduled visits for assessments of wrinkle severity using investigator and patient scales, safety checks, and monitoring of immune response. The primary outcome is measured within 4 weeks, with secondary outcomes evaluated up to 52 weeks. Participants must be willing and able to follow study procedures throughout the trial, which runs until August 2026.

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.