A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients
Public ClinicalTrials.gov record NCT02605434. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.
Study identification
- NCT ID
- NCT02605434
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Interventions
- Accordion Pill™ Carbidopa/Levodopa Drug
- Sinemet® Drug
- Placebo -AP-CD/LD Drug
- Placebo- Sinemet Drug
Drug
Eligibility (public fields only)
- Age range
- 30 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2016 (Type not available)
- Primary completion
- Jul 2019 (Actual)
- Completion
- Dec 2019 (Estimated)
- Last update posted
- Aug 8, 2019
2016 – 2019
United States locations
- U.S. sites
- 36
- U.S. states
- 22
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Alabama Hospital Neurology | Birmingham | Alabama | 35233 | — |
| Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center | Phoenix | Arizona | 85013 | — |
| Parkinson's Disease & Movement Disorders Center, Dept of Neu | Fountain Valley | California | 92708 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| SC3 Research | Pasadena | California | 91105 | — |
| SC3 Research | Reseda | California | 91335 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| University of Colorado Dept. of Neurology | Aurora | Colorado | 80045 | — |
| Hartford HealthCare | Vernon | Connecticut | 06066 | — |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | — |
| Collier Neurologic Specialists, LLC | Naples | Florida | 34102 | — |
| Bioclinica Research | Orlando | Florida | 32806 | — |
| Parkinson's Disease and Movement Disorders Center | Tampa | Florida | 33613 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| Michigan State University | East Lansing | Michigan | 48824 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
| Henry Ford Hospital | West Bloomfield | Michigan | 48322 | — |
| Dartmouth Hitchcock Neurology | Lebanon | New Hampshire | 03756 | — |
| Atlantic Health System Hospital Corp.-Overlook Hospital | Summit | New Jersey | 07902 | — |
| David L. Kreitzman, MD., PC | Commack | New York | 11725 | — |
| Fresco Institute for Parkinson's and Movement Disorders | New York | New York | 10016 | — |
| Weill Cornell Medical College of Cornell University | New York | New York | 10021 | — |
| Asheville Neurology Specialists | Asheville | North Carolina | 28806 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0525 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | — |
| Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences | Nashville | Tennessee | 37232 | — |
| North Texas Movement Disorders Institute | Bedford | Texas | 76021 | — |
| Baylor College of Medicine Department of Neurology | Houston | Texas | 77030 | — |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | — |
| Booth Garner Parkinson's Care Center | Kirkland | Washington | 98034 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02605434, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 8, 2019 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02605434 live on ClinicalTrials.gov.