Positive Results from Mitsubishi Tanabe Pharma America’s Pivotal Phase 3 BouNDless Trial of Investigational ND0612 in Parkinson’s Disease Patients with Motor Fluctuations
Parkinson’s disease is a neurodegenerative disorder that affects millions of people worldwide. It is characterized by the progressive loss of dopamine-producing cells in the brain, leading to motor symptoms such as tremors, stiffness, and difficulty with movement. One of the challenges in managing Parkinson’s disease is the occurrence of motor fluctuations, where patients experience periods of reduced mobility or “off” periods despite being on medication.
Mitsubishi Tanabe Pharma America, a subsidiary of Mitsubishi Tanabe Pharma Corporation, has been working on developing a novel treatment for Parkinson’s disease patients with motor fluctuations. Their investigational drug, ND0612, aims to provide continuous delivery of levodopa and carbidopa, the standard medications used to manage Parkinson’s disease symptoms.
Recently, the company announced positive results from their pivotal Phase 3 BouNDless trial, evaluating the efficacy and safety of ND0612 in Parkinson’s disease patients with motor fluctuations. The trial enrolled 395 participants across multiple centers in the United States and Europe.
The primary endpoint of the study was the change from baseline in daily “off” time, which refers to the periods when patients experience reduced mobility or are unable to perform daily activities due to Parkinson’s symptoms. The trial also assessed secondary endpoints such as “on” time without troublesome dyskinesia (involuntary movements), Unified Parkinson’s Disease Rating Scale (UPDRS) scores, and quality of life measures.
The results of the BouNDless trial demonstrated that ND0612 significantly reduced daily “off” time compared to placebo. Patients treated with ND0612 experienced an average reduction of 2.4 hours per day in “off” time, while the placebo group only had a reduction of 0.5 hours per day. This significant improvement in motor fluctuations is a promising outcome for Parkinson’s disease patients who struggle with the unpredictability of their symptoms.
Furthermore, ND0612 also increased “on” time without troublesome dyskinesia by an average of 1.9 hours per day compared to placebo. Dyskinesia is a common side effect of levodopa treatment, characterized by involuntary movements that can be bothersome and impact a patient’s quality of life. The ability of ND0612 to extend “on” time without troublesome dyskinesia suggests that it may provide a more stable and consistent treatment option for Parkinson’s disease patients.
In addition to the improvements in motor fluctuations, ND0612 also demonstrated a positive impact on UPDRS scores, which assess various aspects of Parkinson’s disease symptoms. Patients treated with ND0612 showed a significant reduction in UPDRS scores compared to placebo, indicating an overall improvement in motor function and disease severity.
The safety profile of ND0612 was also favorable, with no unexpected or serious adverse events reported during the trial. The most common side effects observed were mild to moderate infusion site reactions, which were generally well-tolerated.
The positive results from the BouNDless trial provide hope for Parkinson’s disease patients with motor fluctuations who are seeking more effective and reliable treatment options. The continuous delivery of levodopa and carbidopa through ND0612 has the potential to improve patients’ quality of life by reducing “off” time and extending “on” time without troublesome dyskinesia.
Mitsubishi Tanabe Pharma America plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) based on the results of the BouNDless trial. If approved, ND0612 could become a valuable addition to the treatment armamentarium for Parkinson’s disease, addressing the unmet needs of patients with motor fluctuations.
It is important to note that while the results of the BouNDless trial are promising, further studies and regulatory approvals are required before ND0612 can be made available to patients. However, the positive outcomes from this Phase 3 trial offer a glimmer of hope for Parkinson’s disease patients and their families, bringing us one step closer to a better future for those living with this debilitating condition.
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- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/mitsubishi-tanabe-pharma-america-presents-positive-results-from-pivotal-phase-3-boundless-trial-of-investigational-nd0612-in-people-with-parkinsons-disease-experiencing-motor-fluctuations-drugs-com/