Actively Recruiting
Open-Label Phase 4 Study of CREXONT (Carbidopa and Levodopa) Extended Release Capsules in Parkinson's Disease Patients
Led by Impax Laboratories, LLC · Updated on 2025-08-24
220
Participants Needed
27
Research Sites
39 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
Researchers are evaluating the effectiveness and safety of CREXONT, an extended-release capsule containing Carbidopa and Levodopa, in people with Parkinson disease (PD) under real-world conditions. This Phase 4 study aims to understand how well CREXONT works in reducing motor symptom fluctuations in participants who are already treated with stable oral Carbidopa-Levodopa regimens. Participants will receive CREXONT extended-release capsules orally, with doses guided by FDA-approved prescribing information. The capsules come in several strengths, and dosing will be adjusted individually to find the best balance between effectiveness and tolerability. The study includes an initial dosing based on prior oral medication and allows optimization throughout the study to meet each participant's needs. During the study, participants will complete Parkinson's Disease diaries to track "On" and "Off" motor states, and researchers will measure changes in "Good On" time and "Off" time by Day 42 compared to baseline. Participants will attend study visits and may receive questionnaires and assessments to monitor their condition and treatment response. The study is open-label, meaning all participants receive CREXONT, and the total participation duration includes baseline and follow-up assessments through Day 42.
CONDITIONS
Brief 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...
- Participants diagnosed with Parkinson disease according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria and treated with stable oral Carbidopa-Levodopa regimens
- Score of at least 20 on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score in the "Off" state at screening
- Predictable "Off" periods at screening with Motor Fluctuation complexity score of 1 or 2 on MDS-UPDRS Part IV B
- Experience daily predictable "wearing-off" episodes with worsening motor symptoms and at least 2.5 hours of cumulative "Off" time per day while awake for 4 weeks prior to screening
- Ability to differentiate "On" and "Off" states with at least 75% agreement with a trained rater during training sessions
- Ability to properly complete Parkinson's Disease diaries with valid entries confirmed at baseline
- Responsive to Carbidopa-Levodopa therapy and on a stable regimen for at least 4 weeks prior to baseline, meeting specific dosing frequency and daily dose requirements
- Willing and able to provide written informed consent and comply with study procedures including diaries and visits
- Previous participants in CREXONT clinical studies may be enrolled
You will not qualify if you...
- Any condition or factor that, according to the clinical investigator and CREXONT prescribing information, makes participation inappropriate
- Prior neurosurgical treatment for Parkinson disease or planned neurosurgical procedures before Day 42
- Use of controlled-release Carbidopa-Levodopa doses other than a single bedtime dose within 4 weeks prior to baseline
- Use of Duopa, nonselective MAO inhibitors, rescue medications for "Off" episodes, or investigational drugs within specified timeframes prior to baseline
- Inability to comprehend study materials or complete required diaries and assessments
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 42 days
Participants receive CREXONT extended-release capsules orally, with dosing optimized to balance efficacy and tolerability according to FDA-approved prescribing information.
Visits at Baseline and Day 42
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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