Actively Recruiting
A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
Led by Impax Laboratories, LLC · Updated on 2025-08-24
220
Participants Needed
27
Research Sites
77 weeks
Total Duration
On this page
Sponsors
I
Impax Laboratories, LLC
Lead Sponsor
A
Amneal Pharmaceuticals, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
CONDITIONS
Official Title
A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria and treated with stable oral CD-LD
- Score of at least 20 on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III in the "Off" state
- Have predictable "Off" periods with motor fluctuations as scored on MDS-UPDRS Part IV B
- Experience daily predictable "wearing-off" episodes with worsening motor symptoms for at least 4 weeks prior to screening
- Have at least 2.5 cumulative hours per day of "Off" time while awake
- Able to differentiate "On" and "Off" states with at least 75% agreement with a trained rater during training
- Able to complete Parkinson's Disease diaries properly with valid entries
- Responsive to CD-LD therapy and on a stable regimen for at least 4 weeks prior to baseline
- Taking required minimum doses of CD-LD or Rytary with specified dosing frequencies
- Able and willing to provide written informed consent
- Able and willing to comply with the study protocol, including diary completion and study visits
- Participants from prior CREXONT studies may enroll
You will not qualify if you...
- Considered unsuitable for the study by the clinical investigator based on CREXONT prescribing information
- History of neurosurgical treatment for PD or planned neurosurgery before Day 42 visit
- Use of certain PD treatments within 4 weeks prior to baseline, including multiple CR CD-LD doses (except single bedtime dose), Duopa, nonselective MAOIs, rescue medications for "Off" episodes, or investigational drugs
- Unable to comprehend study requirements or complete PD diaries and patient-reported outcomes
- Employees or family members of the investigator, study staff, or Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Not Yet Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California, United States, 92656
Actively Recruiting
4
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States, 94301
Actively Recruiting
5
Visionary Investigators Network
Aventura, Florida, United States, 33180
Actively Recruiting
6
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Actively Recruiting
7
Univesity of Miami - Miller School of Medicine
Boca Raton, Florida, United States, 33486
Actively Recruiting
8
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
9
N1 Research LLC
Orlando, Florida, United States, 32825
Actively Recruiting
10
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States, 33613
Actively Recruiting
11
Central DuPage Hospital - Movement Disorders Center
Winfield, Illinois, United States, 60190
Not Yet Recruiting
12
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
13
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
14
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Not Yet Recruiting
15
Parkinson's Research Centers of America - Long Island
Commack, New York, United States, 11725
Actively Recruiting
16
Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
17
NeuroScience Research Center, LLC
Canton, Ohio, United States, 44718
Actively Recruiting
18
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
19
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
20
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 73136
Actively Recruiting
21
Neurology Consultants of Dallas, PA
Dallas, Texas, United States, 75243
Actively Recruiting
22
Texas Movement Disorder Specialists, PLLC
Georgetown, Texas, United States, 78628
Actively Recruiting
23
Icahn School of Medicine at Mount Sinai
Houston, Texas, United States, 77030
Not Yet Recruiting
24
The University of Texas Health Science Center at Houston- McGovern Medical School
Houston, Texas, United States, 77030
Actively Recruiting
25
Inova Neurology
Fairfax, Virginia, United States, 22031
Actively Recruiting
26
VCU Parkinsons Disease and Movement Disorders Center
Henrico, Virginia, United States, 23233
Actively Recruiting
27
MedStar Georgetown University Hospital Department of Neurology
McLean, Virginia, United States, 22101
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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