OLE - Extension Study of the Safety and Clinical Utility of IPX203
Research type
Research Study
Full title
AN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS
IRAS ID
269900
Contact name
Yen Foung Tai
Contact email
Sponsor organisation
Impax Laboratories, LLC
Eudract number
2018-002234-21
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 1 months, 15 days
Research summary
Summary of Research
This is a 9-month, multicentre open-label safety extension study. Patients who have successfully completed Study IPX203-B16-02 (A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release Carbidopa-Levodopa in Parkinson’s Disease Patients with Motor Fluctuations) may have the opportunity to enrol in this open-label study. This study will consist of a baseline visit (Visit 1) followed by 3 visits (Visits 2 to 4) spaced at approximately 3-month intervals. For patients who successfully complete Study IPX203-B16-02, the baseline visit (Visit 1) of this study will occur coincident with the End of Study (EOS) Visit 7 of the preceding study. After providing written informed consent, confirmation of eligibility and baseline procedures will be performed. Patients will be initially started on the final IPX203 dosing regimen that was determined during the IPX203 dose conversion period of Study IPX203-B16-02. Investigators are permitted to adjust the dosing regimen of IPX203 during this study to achieve the optimal balance of efficacy and safety and any changes will be recorded.The aim of this study is to evaluate the long-term safety and clinical utility of IPX203 for patients with advanced Parkinson’s disease (PD) who have motor fluctuations and have successfully completed Study IPX203-B16-02.
Summary of Results
Clinical utility outcomes were stable throughout the 9 months of the study and confirmed the clinical utility of IPX203 when dosed 3 times per day.
• The vast majority of subjects reached a stable dosing regimen by 3 months of treatment.
• IPX203 was generally safe and well tolerated throughout the study. Overall, 221 (52.7%) subjects experienced TEAEs (Treatment-Emergent Adverse Event). The most frequently reported TEAEs (≥2% subjects) were dyskinesia (21 [5.0%] subjects), fall (21 [5.0%] subjects), urinary tract infection (21 [5.0%] subjects), back pain (15 [3.6%] subjects), constipation (11 [2.6%] subjects), and COVID-19 (10 [2.4%] subjects).
•The majority of TEAEs were mild to moderate in severity and occurred within the first 90 days of treatment.This study is being conducted at multiple clinical sites in the United Kingdom, United States and Europe.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0379
Date of REC Opinion
5 Feb 2020
REC opinion
Further Information Favourable Opinion