Parana

Researchers are conducting a Phase 3 clinical trial to study the effects of relutrigine in people with developmental and epileptic encephalopathies (DEEs). The study is designed to evaluate the drug's efficacy, safety, tolerability, and how the body processes it compared to a placebo. This trial includes participants aged 2 to 65 years who have experienced seizure onset before age 12 and have a confirmed diagnosis of DEE. Participants will be randomly assigned to receive one of two doses of relutrigine (1.0 mg/kg/day or 1.5 mg/kg/day) or a placebo. The medication is given once daily either by mouth or through a gastrostomy or jejunostomy tube. After the initial double-blind treatment period, there is an open-label extension where all participants may receive the study drug. During the study, participants will be monitored for changes in seizure frequency over 16 weeks as the primary outcome. Safety and tolerability will also be assessed throughout the trial. Various evaluations, including heart monitoring and seizure tracking, will be conducted to ensure participant well-being. The overall study will track participants from screening through treatment and follow-up phases to gather comprehensive data about relutrigine's effects.

Researchers are evaluating the safety and effectiveness of IPN10200, a medication designed to prevent episodic and chronic migraines in adults aged 18 to 80. Migraines cause severe throbbing pain often accompanied by nausea and sensitivity to light and sound, caused by brain activation releasing pain-related chemicals. IPN10200 works by stopping the release of these chemical messengers, and this phase II study aims to find the right dose that balances safety and efficacy. The study has three periods: first, a screening to check eligibility; second, Step 1 where two different doses of IPN10200 are tested sequentially in two groups, with injections given into muscles of the head, face, and neck and safety monitored over 36 weeks; third, Step 2 where new participants with episodic or chronic migraine are randomly assigned to receive one of two doses or a placebo, also via injections in the same areas, with monitoring continuing until Week 36. Participants will complete a daily electronic migraine diary and questionnaires throughout the study lasting up to 44 weeks. Researchers will monitor safety by tracking adverse events, laboratory changes, vital signs, facial exams, ECG readings, and antibody development. They will also measure changes in monthly migraine days to evaluate treatment effectiveness while ensuring participant safety throughout the study.

Researchers are evaluating whether lymphatic surgery improves quality of life compared to conservative treatment for patients with chronic breast cancer-related lymphedema (BCRL). This study compares surgical techniques that restore lymphatic drainage with the current standard conservative complex physical decongestion therapy (CDT). The trial is a pragmatic, randomized, multicenter study aiming to provide solid evidence on the benefits of surgery over conservative care for BCRL patients. The surgical intervention includes lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT), which may be done alone or combined, sometimes with liposuction, in one or two stages based on the surgeon's decision and local standards. Patients in the control group receive CDT, which involves manual lymphatic drainage, compression, exercises, and skin care, delivered by specialized physical therapy clinics according to standard practice. Participants will be assessed at baseline and again 15 months after randomization to measure changes in quality of life using the Lymph-ICF-UL questionnaire. Researchers will monitor patient outcomes, quality of life, and safety throughout the study period. The study includes adults with chronic BCRL who have previously undergone conservative therapy and are willing to participate in surgery or continue conservative treatment.