In a nutshell
This study evaluated the effectiveness and safety of the ND0612 delivery system of levodopa/carbidopa (Sinemet) in patients with Parkinson's disease (PD). The authors showed that the system was well-tolerated and safe and that it reduced the fluctuations of the levodopa plasma levels.
Parkinson's disease (PD) is the second most common neurodegenerative disorder. In PD, part of the brain is progressively damaged over many years. The main cause is the loss of nerve cells in a part of the brain called "substantia nigra". This leads to a reduction in a molecule involved in the body's movement, called dopamine. Therefore, common PD symptoms include involuntarily shaking of particular parts of the body (tremor), slow movements, and stiff and inflexible muscles.
Levodopa is the most effective therapy to treat the motor symptoms of PD. However, over time patients need higher and higher doses of the medications as they experience fluctuations of the effect. This translates into periods during which the drug does not work called "off periods" and the administration of the next dose earlier than usual. For patients with motor response fluctuations, continuous levodopa infusion through the skin (subcutaneous) is considered the optimal delivery route.
ND0612 (NeuroDerm, Rehovot, Israel) is a subcutaneous delivery system that has been designed to provide a continuous and stable levodopa/carbidopa level in the blood and to provide minimal invasiveness. The safety and effectiveness of ND0612 remain under investigation.
Methods & findings
The study included patients with PD who were experiencing motor fluctuations of at least 2 hours per day. The study included two periods. During Period-1, patients were randomly assigned to receive either ND0612 or a placebo in addition to their current standard of care (SoC) treatment. This period lasted for 2 weeks. The first 16 patients that completed Period-1 were then included in Period-2. During Period-2, patients were randomly assigned to receive either ND0612 alone or ND0612 plus oral entacapone (Comtan) for 1 week. During Period-2, patients reduced or completely stopped their oral levodopa/carbidopa dose, based on their neurologist’s judgment.
During Period-1, patients receiving ND0612 needed lower doses of oral levodopa/carbidopa (514 mg) compared to the placebo group (669 mg). Also, during Period-1, the group that received ND0612 experienced an average reduction of "off" time of 2.13 hours after 15 days. This was compared to a reduction of 1.4 hours in the placebo group. After 15 days, 89% of patients treated with ND0612 reported improved overall symptoms compared to 36% in the placebo group.
During Period-2, the addition of entacapone to ND0612 treatment led to an increase in the concentration of levodopa blood levels.
There were no reports of other side effects of ND0612 compared to the oral levodopa/carbidopa, except for mild to moderate skin reaction at the infusion site. These included redness, pain, and nodules but were transitory.
The bottom line
The study concluded that the ND0612 delivery system was safe and well-tolerated by patients with PD. This new delivery system provided continuous and stable plasma levels of levodopa when compared to placebo.
The fine print
This study included a very small number of participants and had a very short follow-up period. Larger studies are on the way. This study was funded by NeuroDerm, the manufacturer of the ND0612 delivery system.
Published By :
Parkinsonism & related disorders
Oct 01, 2021
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