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

Detailed criteria

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…

Locations (27)

Barrow Neurological Institute
Phoenix, Arizona
MovementResearch@dignityhealth.org 602-406-4280
University of Arkansas for Medical Sciences
Little Rock, Arkansas
rdhall@uams.edu 501-526-5282
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California
Bixby_research@parkinsonscenter.org 949-738-1613
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California
info_PaloAlto@parkinsonscenter.org 650-394-6690
Visionary Investigators Network
Aventura, Florida
DrJ@aventuraneuro.com 305-933-5993
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida
info@parkinsonscenter.org 561-392-1818

Summary

Eligibility

Interventions

Locations (27)