A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
NCT ID: NCT06765668
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
220 participants
INTERVENTIONAL
2025-02-12
2026-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CREXONT ER
Participants will receive CREXONT extended release (ER) capsules, orally, as guided by the Food and Drug Administration (FDA) approved prescribing Information. CREXONT ER capsules will contain Carbidopa (CD)/Levodopa (LD) 35.0 milligrams (mg)/140 mg and/or CD/LD 52.5 mg/210.0 mg and/or CD/LD 70.0 mg/280 mg and/or CD/LD 87.5 mg/350 mg. The initial CREXONT dosing regimen will be based on the FDA approved CREXONT prescribing information for dose conversion from prior oral CD-LD medications to CREXCONT. Thereafter the dosing regimen can be optimized as appropriate for the condition of each participant and guided by the FDA approved CREXONT prescribing information, in order to achieve the optimal balance of efficacy and tolerability for each participant.
CREXONT ER
CREXONT ER capsule.
Interventions
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CREXONT ER
CREXONT ER capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 days) prior to Screening, the participant experiences.
1. Daily predictable "wearing-off" episodes with periods of worsening motor symptoms.
2. An average of at least 2.5 cumulative hours per day of "Off" time, during the hours the participant awake.
5. At Screening, the participant is able to differentiate "On" state from "Off" state as determined by at least 75 percentage (%) concordance with a trained rater (that is, investigator or qualified and certified site staff) in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least one "On" and one "Off" rating in this 4-hour training period.
1. If the concordance is less than 75%, or if it does not include at least one "On" and one "Off" rating within the first 4-hour training period, a second 4-hour training period should be conducted with the participant before being considered for inclusion in the study.
2. If during the second 4-hour training-period a concordance of at least 75% is also not achieved, or if it does not include at least one "On" and one "Off" rating, the participant cannot be included in the study.
6. At baseline (Visit 1), review of the 3-day PD diaries confirms the following:
1. The participant is able to properly complete the PD diaries with valid entries. Inability to properly complete the diaries is indicated when more than 1 day of a diary is not returned or if more than 1 day of the diary is not valid (that is, more than 2 hours \[4 half-hour periods\] of the 24-hour diary day are missing); and
2. The participant has an average of at least 2.5 hours per day of "Off" time, during the hours the participant is awake, over the 3 PD diary days; and
3. The participant has at least 1.5 hours of cumulative "Off" time, during the hours the participant is awake, on each of the 3 PD diary days.
7. Participant is responsive to CD-LD therapy and currently being treated on a stable regimen of oral CD-LD for at least 4 weeks (greater than equal to \[\>=\] 28 days) prior to baseline (Visit 1) and meets the following criteria:
a. Daily Dose Requirements: i. All participants should be taking at least 100 mg of immediate-release (IR) CD-LD or 195 mg of Rytary for the first morning dose.
ii. For participants taking IR CD-LD (with or without a bedtime dose of CR CD-LD):
* Require a total daily dose of at least 300 mg of LD and a maximum total daily dose of less than equal to \[\<=\]1200 mg LD (from IR CD-LD alone or from IR CD-LD in combination with a single daily bedtime dose of CR CD-LD).
* The maximum individual dose allowed is 250 mg of LD.
* The minimum individual dose should be at least 100 mg of LD. iii. For participants using a catechol-O-methyltransferase (COMT) inhibitor:
* Require a total daily dose of at least 300 mg of LD and a maximum total daily dose of less than \[\<\]1000 mg LD.
* The maximum individual dose is 200 mg of LD. iv. For participants using Rytary:
* Require a total daily dose of at least 585 mg of LD and a maximum total daily dose of \<2100 mg LD.
* The maximum individual dose is 685 mg of LD. b. Dose Frequency Requirement: i. If a participant is using IR/CR CD-LD alone or in combination with a COMT inhibitor, then the dosing frequency must be 3 to 6 times daily. ii. If a participant is using Rytary, then the dosing frequency must be 3 to 4 times daily.
8. Participant is able and willing to provide written informed consent prior to the conduct of any study-specific procedures.
9. Participant is able and willing to comply with the protocol, including completion of PD diaries, questionnaires, and available for all study visits and telephone calls.
10. Participants who have participated in prior CREXONT clinical studies are allowed to be enrolled in this Phase 4 study.
Exclusion Criteria
2. Participant had a prior neurosurgical treatment for PD (example, deep brain stimulation \[DBS\] surgery or neurosurgical ablation treatment procedures) or if such procedure is planned or anticipated prior to Visit 4 (Day 42) of the study.
3. Participant received the following within 4 weeks (\<=28 days) prior to baseline (Visit 1)
1. Any doses of a CR CD-LD apart from a single daily bedtime dose.
2. Duopa.
3. Nonselective monoamine oxidase inhibitor (MAOI).
4. Rescue medication used to treat "off" episodes for example: apomorphine or inhaled LD (Inbrija®).
5. Received any investigational drugs within 30 days or 5 times the half-life, whichever is longer, prior to baseline (Visit 1).
4. Participant who, in the opinion of the clinical investigator, should not participate in the study (example, based on clinical assessment, participant does not adequately comprehend the terminology needed to complete the PD diary and participant -reported outcomes, or any other reason).
5. Employees or family members of the investigator, or study site staff, or Sponsor.
18 Years
ALL
No
Sponsors
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Amneal Pharmaceuticals, LLC
INDUSTRY
Impax Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Hester Visser, MD
Role: STUDY_DIRECTOR
Amneal Pharmaceuticals, LLC
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Parkinson's Research Centers of America - Orange County
Aliso Viejo, California, United States
Parkinson's Research Centers of America - Palo Alto
Palo Alto, California, United States
Visionary Investigators Network
Aventura, Florida, United States
Parkinsons Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Univesity of Miami - Miller School of Medicine
Boca Raton, Florida, United States
University of Miami
Miami, Florida, United States
N1 Research LLC
Orlando, Florida, United States
USF Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Central DuPage Hospital - Movement Disorders Center
Winfield, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Parkinson's Research Centers of America - Long Island
Commack, New York, United States
Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower
Winston-Salem, North Carolina, United States
NeuroScience Research Center, LLC
Canton, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Neurology Consultants of Dallas, PA
Dallas, Texas, United States
Texas Movement Disorder Specialists, PLLC
Georgetown, Texas, United States
Icahn School of Medicine at Mount Sinai
Houston, Texas, United States
The University of Texas Health Science Center at Houston- McGovern Medical School
Houston, Texas, United States
Inova Neurology
Fairfax, Virginia, United States
VCU Parkinsons Disease and Movement Disorders Center
Henrico, Virginia, United States
MedStar Georgetown University Hospital Department of Neurology
McLean, Virginia, United States
Countries
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Facility Contacts
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Other Identifiers
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IPX203-401-23
Identifier Type: -
Identifier Source: org_study_id
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