Investigating the effectiveness and safety of ND0612, an investigational medicine for patients with advanced Parkinson’s Disease
ND0612 is a novel liquid formulation of levodopa/carbidopa (LD/CD) aimed to reduce motor complications in patients with advanced Parkinson’s Disease.
ND0612 is designed in low-dose (ND0612L) and high-dose (ND0612H), administered subcutaneously (just under the skin) through a mini-pump, enabling 24-hour continuous LD/CD administration.
In a phase II placebo controlled study, ND0612L was shown to maintain steady, therapeutic levodopa plasma concentrations that were associated with major changes in clinical parameters such as “OFF time” reduction when added to optimal oral standard of care.1
In a phase IIa study, ND0612H was shown to reach higher levodopa steady plasma levels,2 indicating that it may provide an effective alternative to current treatments requiring surgery, such as deep brain stimulation and LD/CD Intestinal Gel.
ND0612 CLINICAL STUDIES
TREATMENT DURATION: 4-52 WEEKS
YOU MAY BE ELIGIBLE TO PARTICIPATE IN THESE STUDIES IF YOU ARE:
- 30 to 80 years old
- Taking at least 4 doses/day of levodopa
- Experiencing a minimum of 2-2.5 hours of “OFF” time per day with predictable early morning “OFF” periods
IF YOU OR A LOVED ONE ARE BEING TREATED FOR ADVANCED PARKINSON’S DISEASE, CONSIDER ND0612 CLINICAL STUDIES
Most medications for Parkinson’s Disease begin to lose effectiveness after several years of use. Without access to an effective medication, patients with Parkinson’s Disease begin to experience more “OFF” periods, which have a significant impact on daily life. Treatments that reduce “OFF time” are needed.
Pharmaceutical companies use research studies like the ones for which we are enrolling patients to learn more about investigational medications before they are made available to the public. The results of these studies will provide more information about the investigational medication’s effect on Parkinson’s Disease. By taking part in these studies, you may contribute to the development of medications for Parkinson’s Disease patients in the future.
ND0612 CLINICAL STUDIES
ND0612 clinical studies are evaluating an investigational Parkinson’s Disease treatment that uses a pump system to deliver an infusion of the investigational medication, a solution of levodopa and carbidopa, through a small needle that is inserted beneath the skin.
By using an infusion to deliver the investigational medication continuously, it could offer more effective control of “OFF” periods than oral medications. Researchers designed these clinical studies to protect the rights and welfare of those participating. Independent review boards reviewed and approved these research protocols and related materials (e.g. explanatory documents and informed consents), and will monitor the progress of the studies.
Currently, only patients who participate in research studies like these can receive the investigational medication. It is not approved by regulatory agencies for the treatment of Parkinson’s Disease. As with any medical research study, the investigational medication is not guaranteed to help your Parkinson’s Disease.