BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe Cleveland Clinic
About this trial
The purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.
Eligibility criteria
Qualifiers
- Participant is 40 years or older
Diagnosed with idiopathic Parkinson's disease and is deemed to be levodopa responsive
Baseline MDS-UPDRS score in OFF-state is > 20
Patient is being treated with a stable regimen of CD-LD for at least four weeks
Disqualifiers
- Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV
Currently on device-aided therapies for advanced PD
Using controlled-release CD-LD apart from a single daily bedtime dose
Using "on demand" therapy unless willing to stop it during the study period
Trial design
Treatments tested in this trial
- CREXONT ER
Treatment groups
22 Participants
are divided into 1 treatment groupSponsors and collaborators
The Cleveland Clinic
Lead sponsor
Amneal Pharmaceuticals, LLC
Collaborator
Source ClinicalTrials.gov