Loading...
Please wait, while we are loading the content...
Similar Documents
ND0612 – a Newly Developed Liquid Levodopa/Carbidopa Formulation Administered Continuously Subcutaneously by a Mini-pump – Patient Use Perspective (P1.025)
| Content Provider | Semantic Scholar |
|---|---|
| Author | Nash, Sophie Gera, Moran Shor, Eran Minei, Tamar Rachmilewitz Oren, Sheila |
| Copyright Year | 2017 |
| Abstract | Objective: to examine the usability of the ND0612 associated mini-pump among patients with moderate-severe PD. Background: ND0612 is an investigational drug-device combination utilizing the first and only liquid formulation of levodopa/carbidopa (LD/CD) administered continuously subcutaneously by a mini-pump. In clinical studies to date, ND0612 was shown to achieve constant levels of LD in the blood and improvement in disease symptoms such as off time. Design/Methods: 15 PD patients, along with their partner were invited to partake in 4 sessions of 90 minutes during which they were trained on how to set up and operate the pump system. Participants also simulated the infusion to a dummy skin pad. For the training process, training aids such as step-by-step live demonstration and use of a highly pictorial patient guide were used as well as a quick link for a 24/7 helpline. The outcomes measures were the ability to assemble and operate the pump independently or with the help of a caregiver and to comprehend and appropriately respond to potential use errors. Results: All of the 15 pairs that participated in the study were able to assemble and operate the pump following training, demonstrating user-learning ability and overall user satisfaction from the device use. Training materials were shown to be effective in aiding PD patients to achieve safe and effective operation of the pump. Despite inherent motor difficulties, patients were able to perform the tasks requiring fine motor skills such as drug loading and connection of infusion line. Conclusions: From the user perspective, the ND0612-associated device is well perceived by PD patients and their caregivers, following appropriate and effective training and the use of training aids. ND0612 product candidate offers a novel, patient-controlled, easy to use solution to achieve constant levels of LD in the blood that today can be achieved only after surgical intervention. Study Supported by: NeuroDerm Ltd. Disclosure: Ms. Nash has received personal compensation for activities with NeuroDerm Ltd. Dr. Gera has received personal compensation for activities with NeuroDerm Ltd. as an employee. Dr. Shor has received personal compensation for activities with NeuroDerm Ltd. as an employee. Dr. Rahmilevich has received personal compensation for activities with NeuroDerm Ltd., a an employee. Dr. Oren has received personal compensation for activities with NeuroDerm Ltd. |
| File Format | PDF HTM / HTML |
| Volume Number | 88 |
| Alternate Webpage(s) | http://neuroderm.com/PDF/Poster-presented-at-theMDS-Vancouver-2017-patient-use-perspective.pdf |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
