Open-Label Phase 4 Study of CREXONT® (Carbidopa and Levodopa) Extended Release Capsules in Parkinson's Disease Patients
Impax Laboratories, LLC
Summary
The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants with PD consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of oral CD-LD. 2. Participants with a score of at least 20 units at Screening on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score in the "Off" state. 3. Participants with predictable "Off" periods at Screening defined by a score of 1 or 2 (Complexity of Motor Fluctuations) of the MDS-UPDRS Part IV B (Motor Fluctuations). 4. By history, for the 4 weeks (28…
Interventions
- DrugCREXONT ER
CREXONT ER capsule.
Locations (27)
- Barrow Neurological InstitutePhoenix, Arizona
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Parkinson's Research Centers of America - Orange CountyAliso Viejo, California
- Parkinson's Research Centers of America - Palo AltoPalo Alto, California
- Visionary Investigators NetworkAventura, Florida
- Parkinsons Disease and Movement Disorders Center of Boca RatonBoca Raton, Florida