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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

CREXONT ER
Drug
exploring shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods

Treatment groups

22 Participants

are divided into 1 treatment group

Group A: Intervention ArmOther 1 intervention

Trial outcomes

Primary outcomes

Primary Endpoint

Mean change in the average duration of good on-time from baseline to end of study

Time frame

8 weeks

Secondary outcomes

Secondary Endpoint

Mean change in the average 'slowness' scores as measured by KinesiaU

Time frame

8 weeks

Secondary Endpoint

Mean change in time spent with tremor as measured by KinesiaU

Time frame

8 weeks

Secondary Endpoint

Mean change in the average tremor scores as measured by KinesiaU

Time frame

8 weeks

Secondary Endpoint

Mean change in time spent with dyskinesia as measured by KinesiaU

Time frame

8 weeks

Other outcomes

Exploratory Endpoints

Mean difference between KinesiaU and PD diary measurements of change in good on-time from baseline to end of study

Time frame

8 weeks

Exploratory Endpoint

Difference in the Patient Global Impression of Change from baseline to end of study.

Time frame

8 weeks

Exploratory Endpoint

Difference between Non-Motor Fluctuation Assessment Questionnaire from baseline to end of study.

Time frame

8 weeks

Exploratory Endpoint

The average time (in weeks) taken to reach the final dose.

Time frame

8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Amneal Pharmaceuticals, LLC

Collaborator

Source ClinicalTrials.gov

Apply now