Kassel

Researchers are evaluating the effectiveness and safety of Xeomin injections in preventing chronic migraine. This Phase 3 clinical trial compares Xeomin to placebo injections given into muscles of the head and neck. Participants have chronic migraine diagnosed for at least 12 months and meet specific headache and migraine day criteria. The study aims to measure changes in monthly migraine days over time with Xeomin treatment. Participants will receive four treatments spaced about 12 weeks apart over a total study duration of 52 to 55 weeks. The treatments involve injections of either Xeomin or placebo solution prepared with sodium chloride. Visits occur approximately every 4 weeks, totaling 14 visits: the first, last, and four treatment visits are on-site, while the other eight visits are remote via phone or video call. During the study, participants will keep headache diaries to track migraine and headache days. Researchers will focus on the change in monthly migraine days from baseline to six months after the first injection. Safety and effectiveness are monitored throughout, with frequent assessments during both on-site and remote visits to ensure accurate tracking of migraine symptoms and any side effects.

Researchers are evaluating the effect of Xeomin injections compared to placebo injections for preventing episodic migraine. This phase 3 clinical trial focuses on adults who experience episodic migraine, aiming to measure changes in the number of migraine days per month. Participants must have a diagnosis of episodic migraine for at least 12 months and meet specific headache frequency criteria. Participants will receive four treatments of either Xeomin or placebo injections into muscles of the head and neck, with treatments spaced about 12 weeks apart. The entire trial lasts approximately 52 to 55 weeks, beginning with a screening period of 4 to 5 weeks. There are about 14 visits in total, with the first, last, and four treatment visits conducted on-site, while the other visits are held remotely via phone or video. Throughout the study, participants will track their migraine days using a headache diary, and researchers will assess changes in monthly migraine frequency from baseline to six months after the first injection. Regular monitoring includes both in-person and remote assessments. The primary outcome focuses on the change in monthly migraine days between baseline and month six after treatment initiation.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

Researchers are evaluating treatments for adults with early-stage (stage II to IIIB) non-small cell lung cancer who are scheduled for surgery. The study aims to compare an investigational treatment combining the immunotherapy drug cemiplimab, chemotherapy, and a third drug against cemiplimab plus chemotherapy alone. The trial also explores side effects of these treatments, effects on the type of surgery performed, drug levels in the blood, and whether the body produces antibodies that might affect the treatment's effectiveness or cause side effects. Participants receive treatments through intravenous infusions. One group receives cemiplimab plus chemotherapy, while the other group receives cemiplimab, chemotherapy, and an additional drug called REGN7075. The treatments are given before surgery with the goal of shrinking tumors. The study is a randomized Phase 2 platform trial designed to assess these combined therapies in a perioperative setting. During the study, participants undergo evaluations including pathology reviews up to 12 weeks after treatment to determine tumor response. Researchers monitor major pathological responses and collect tumor samples. Safety and side effects are closely followed. Overall, the study involves treatment, surgery, and follow-up assessments to understand how well the treatments work and their safety profiles.

Researchers are evaluating the safety and effectiveness of NT 201, a botulinum toxin drug, compared with a placebo in adults who have moderate to severe platysma prominence, which involves prominent neck bands. This Phase 3 study is conducted in Europe and focuses on improving the appearance of these neck muscles. The study aims to see how well NT 201 works and how safe it is for participants with this condition. Participants will receive either NT 201 or a matching placebo injection, which contains Clostridium Botulinum neurotoxin A without complexing proteins. The study has two parts: the Main Period (MP), where the initial treatment is given and evaluated, and an Open Label Extension Period (OLEX) that follows. The effectiveness is primarily measured by improvement on the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) at two weeks after treatment. During the study, participants will be assessed by both investigators and themselves for platysma band severity and improvement. Safety and treatment outcomes will be monitored throughout the study periods. The total involvement includes screening, treatment, and follow-up assessments to observe the drug's impact and any side effects over time.

Researchers are evaluating the safety, effectiveness, and how the body processes zipalertinib in adults with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has specific mutations in the Epidermal Growth Factor Receptor (EGFR) gene, including exon 20 insertions and other uncommon mutations. This Phase 2b study also explores potential drug interactions of zipalertinib with certain enzyme and transporter substrates and aims to find the best dosing plan for the medication. Participants will be enrolled into one of four main groups based on their specific EGFR mutation status and treatment history. These groups include those previously treated with exon 20 insertion agents, those untreated and unsuitable for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Additionally, separate substudies will assess drug interactions using enzyme and transporter probe cocktails and will test different doses of zipalertinib in randomized groups until treatment discontinuation. Throughout the study, participants will undergo regular assessments including imaging scans, neurological exams, and laboratory tests to monitor disease progression and treatment safety. Researchers will track response rates over up to two years and evaluate brain metastasis stability when applicable. Safety monitoring, including cardiac function and adverse effects, will be ongoing. The study requires tissue samples to confirm mutation status and participants will be followed closely to evaluate the medication's impact and tolerability.

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

This research aims to evaluate the effectiveness and safety of a single dose of IPN10200 compared to a placebo in adults with moderate to severe glabellar lines, which are wrinkle-like lines that appear between the eyebrows and may affect appearance and confidence. The study includes a double-blind phase to assess initial treatment effects and an open-label phase to evaluate the safety and effectiveness of repeat doses over time. This Phase III study focuses on adult participants aged 18 to 80 years with moderate to severe lines who are dissatisfied with their appearance. Participants will receive injections of either IPN10200 or placebo during the first treatment cycle in the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase will receive IPN10200, with some eligible for up to four treatment cycles. Each treatment involves local injections of a lyophilised powder solution into several sites across the glabellar region. The study consists of three periods: a screening period of up to 20 days, a treatment period with multiple visits especially in the first month followed by monthly visits, and a 24-week follow-up after the last injection. Throughout the study, participants will have health evaluations including blood tests, physical exams, clinical assessments, and electrocardiograms. They will complete questionnaires and keep diaries to monitor their condition and response to treatment. The main outcome measured is the percentage of participants showing improvement in glabellar lines by week 4. Safety and long-term effects will be monitored for up to 107 weeks, with participants free to withdraw consent at any time.