Objective: Development of a treatment for nocturnal and early morning OFF symptomology in Parkinson’s disease.
Background: Levodopa Parkinson’s disease (PD) treatment is limited by its short duration of effect and fluctuations in blood concentrations. Early wearing off during nighttime results in often-troublesome nocturnal symptoms and early morning OFF (EMO), particularly in patients with the onset of motor fluctuations. CLE-600 is being developed as a night pill for the treatment of PD nocturnal symptoms and EMO using a proprietary Oral Long Acting Release (OLAR®) drug delivery platform. CLE-600 is designed to achieve stable and prolonged levels of Levodopa/carbidopa (LD/CD) above night therapeutic levels for 8-10hr, to enable Parkinson patient’s symptomatic control during the night and into the early morning.
Method: 18 healthy volunteers received Sinemet® 100/25 mg (LD/CD) tablet serving as the reference group for CLE-600. After a washout period of at least 48 hours, the subjects were administered CLE-600. Blood samples were collected at different time points between pre-dose and 24 hours post administration and assayed for plasma levodopa concentration. Subjects were also examined by fluoroscopy for the detection and location of the OLAR®.
Results: Following CLE-600 administration, stable LD levels were detected for more than 8hrs. Radiographic examination revealed that each OLAR® was fully open in the stomach within 10 minutes of administration and still present in the stomach at least 8 hours later. The administration of CLE-600 was safe and well tolerated, and a prolonged pharmacokinetic Levodopa profile was achieved.
Conclusion: The ability to treat PD night symptomology and early morning OFF, is a high unmet need in Parkinson’s disease and among the main reasons for low Quality of Life (QoL) reported by PD patients. CLE-600 is being developed as the first oral solution dedicated for PD nocturnal problems and morning akinesia. CLE-600 results warrant further development and testing in Parkinson’s patients experiencing nocturnal symptoms and EMO.
To cite this abstract in AMA style:
E. Berkovich. CLE-600: Treating nocturnal and early morning OFF symptomology in Parkinson’s disease with the OLAR® platform [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/cle-600-treating-nocturnal-and-early-morning-off-symptomology-in-parkinsons-disease-with-the-olar-platform/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/cle-600-treating-nocturnal-and-early-morning-off-symptomology-in-parkinsons-disease-with-the-olar-platform/