Beelitz

Researchers are evaluating the efficacy, safety, and how the body processes pharmacokinetics prasinezumab compared with a placebo in people with early-stage Parkinsons disease PD who are on stable levodopa monotherapy. This Phase III study aims to understand if prasinezumab can affect the progression of motor symptoms in this population. Participants will receive either prasinezumab or a placebo as an intravenous IV infusion during the double-blind treatment period. After completing this phase, eligible participants may enter an open-label extension where they can receive prasinezumab. Infusions are given according to a schedule detailed in the study protocol. Throughout the study, participants will be regularly assessed using the Movement Disorder Society - Unified Parkinsons Disease Rating Scale MDS-UPDRS Part III to monitor motor progression, along with other clinical measures and safety evaluations. Researchers will also track adverse events, antibody development against the drug, and drug levels in the blood. The study includes monitoring up to at least 104 weeks, with safety follow-up extending 70 days after the final dose.

Researchers are evaluating the efficacy and safety of NIO752 in adults aged 41 to 81 with Progressive Supranuclear Palsy Richardson Syndrome PSP-RS, a rare neurological disorder. This Phase III randomized, double-blind, placebo-controlled study compares NIO752 to a placebo in participants with mild to moderate PSP, with symptoms starting less than five years ago. The study is sponsored by Novartis Pharmaceuticals and includes an open-label extension after the initial treatment period. Participants will be randomly assigned in a 21 ratio to receive either NIO752 solution or a placebo solution. After completing the double-blind treatment phase, all participants will have the option to continue receiving NIO752 in an open-label extension. The study monitors changes over 72 weeks, with various assessments including brain imaging and biomarker analysis. During the study, participants and their reliable study partners will attend regular visits for evaluations such as cognitive testing, daily living activities, and safety monitoring. Researchers will measure changes from baseline in PSP rating scales and other neurological functions. Safety will be assessed by tracking adverse events, and the total participation may last up to several years including the open-label extension.

Researchers are evaluating the oral drug TEV-56286 for treating adults aged 30 to 75 with Multiple System Atrophy MSA, a rare and progressive neurological disorder. This Phase 2, double-blind, placebo-controlled study aims to assess the drugs effectiveness, safety, and tolerability over 56 weeks, including screening, treatment, and follow-up. The study includes participants considered clinically possible or probable MSA based on specific criteria and is conducted across multiple countries. Participants will be randomly assigned to receive either TEV-56286 capsules or a matching placebo once daily by mouth during a 48-week double-blind treatment period. Before treatment, they undergo up to 4 weeks of screening, and after treatment, a follow-up visit occurs about 4 weeks later. The study spans approximately 27 months in total. During the trial, participants will have regular assessments including neurological and physical exams, clinical rating scales such as the Modified Unified Multiple System Atrophy Rating Scale UMSARS, MRI scans to measure brain structures, walking tests, and quality-of-life questionnaires. Researchers will monitor for treatment-emergent side effects and collect safety data through vital signs, lab tests, and ECGs. The main outcomes focus on changes in MSA symptoms and disease progression from baseline to week 48.

Tremors, such as those experienced by patients with Parkinsons disease and essential tremor, can be resistant to medication, leading to early use of invasive treatments like deep brain stimulation. There are few effective non-drug treatment options available, and tremors often severely limit daily activities, requiring support from caregivers. This research evaluates the use of the VILIM ball device, a portable, non-invasive vibrating therapy ball designed to reduce hand tremors temporarily and improve everyday functioning in patients with various tremor syndromes. The study compares the effects of the VILIM vibrating therapy ball when active Ball-On versus inactive Ball-Off in patients with Parkinsons tremor, essential tremor, and other tremor types. The device is customized during a training phase to the patients tremor and is intended for use at home or in professional settings. The therapy aims to reduce tremor intensity up to 50%, with effects lasting up to four hours, potentially helping patients perform tasks like eating and writing more easily. Participants will undergo assessments before and after using the therapy ball, including physician and patient evaluations using Clinical Global Impression Severity and disease-specific tremor scales such as MDS-UPDRS III and TETRAS. Tremor analysis data from accelerometers and functional tests like mini darts, writing tasks, and daily activities will also be collected. Independent physicians will review video recordings of evaluations in a single-blinded manner. The study measures the impact on tremor and daily function over a two-year period, with involvement in various tests and observation of therapy effects.

This research aims to systematically record the results of routine laryngeal examinations and specific swallowing difficulties in patients with various neurodegenerative diseases such as Multiple System Atrophy MSA, Progressive Supranuclear Palsy PSP, Parkinsons Disease, Motor Neuron Disease MND, and other related conditions. These disorders often lead to swallowing problems known as dysphagia, which can cause serious complications like dehydration, malnutrition, and pneumonia. The study seeks to better understand how these swallowing issues vary with different disease types and stages. Participants undergo a fiberoptic or flexible endoscopic evaluation of swallowing FEES using a structured task protocol designed to assess laryngopharyngeal function. When available, laryngeal electromyography EMG results are also collected. The study includes patients diagnosed according to established diagnostic criteria for their specific neurodegenerative disorder. Data collected also include demographic information and disease-specific details, along with responses to two questionnaires assessing swallowing disturbances and quality of life related to swallowing. During the study, participants will have their swallowing function assessed through FEES and complete questionnaires about their swallowing difficulties and quality of life. Researchers will evaluate laryngeal movement disorders and dysphagia as primary outcomes. This observational study does not involve any treatment intervention and aims to follow participants over time to categorize swallowing issues and correlate them with their disease subtype. The study has been ongoing since 2017 and plans to continue recruitment and data collection through 2028.