A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease

NCT06765668 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IPX203-401-23
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 27

Brief 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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in "GOOD ON" time per the Parkinson's Disease Diary to Day 42

  "GOOD ON" time is derived from the 3-day Parkinson's disease (PD) diaries. For each day, "GOOD ON" time is calculated by adding the number of half-hour intervals in which either an "on time without dyskinesia" or "on time with non-troublesome dyskinesia" is checked.

  Baseline, Day 42

Secondary Outcomes (1)

• Change From Baseline in "OFF" time per the PD Diary to Day 42

  Baseline, Day 42

Study Arms (1)

CREXONT ER

EXPERIMENTAL

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.

Drug: CREXONT ER

Interventions

CREXONT ER DRUG

CREXONT ER capsule.

Also known as: IPX203

CREXONT ER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• By history, for the 4 weeks (28 days) prior to Screening, the participant experiences.
• Daily predictable "wearing-off" episodes with periods of worsening motor symptoms.
• An average of at least 2.5 cumulative hours per day of "Off" time, during the hours the participant awake.
• 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.
• 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.
• At baseline (Visit 1), review of the 3-day PD diaries confirms the following:
• 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
• 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
• 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.
• 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):

You may not qualify if:

• Participant who, in the opinion of the clinical investigator, should not participate in the study based on the CREXONT Prescribing Information.
• 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.
• Participant received the following within 4 weeks (\<=28 days) prior to baseline (Visit 1)
• Any doses of a CR CD-LD apart from a single daily bedtime dose.
• Duopa.
• Nonselective monoamine oxidase inhibitor (MAOI).
• Rescue medication used to treat "off" episodes for example: apomorphine or inhaled LD (Inbrija®).
• Received any investigational drugs within 30 days or 5 times the half-life, whichever is longer, prior to baseline (Visit 1).
• 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).
• Employees or family members of the investigator, or study site staff, or Sponsor.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead
• Amneal Pharmaceuticals, LLC: collaborator

Study Sites (27)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

NOT YET RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Parkinson's Research Centers of America - Orange County

Aliso Viejo, California, 92656, United States

RECRUITING

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, 94301, United States

RECRUITING

Visionary Investigators Network

Aventura, Florida, 33180, United States

RECRUITING

Parkinsons Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

RECRUITING

Univesity of Miami - Miller School of Medicine

Boca Raton, Florida, 33486, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

N1 Research LLC

Orlando, Florida, 32825, United States

RECRUITING

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

RECRUITING

Central DuPage Hospital - Movement Disorders Center

Winfield, Illinois, 60190, United States

NOT YET RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

NOT YET RECRUITING

Parkinson's Research Centers of America - Long Island

Commack, New York, 11725, United States

RECRUITING

Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower

Winston-Salem, North Carolina, 27157, United States

RECRUITING

NeuroScience Research Center, LLC

Canton, Ohio, 44718, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 73136, United States

RECRUITING

Neurology Consultants of Dallas, PA

Dallas, Texas, 75243, United States

RECRUITING

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, 78628, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

Houston, Texas, 77030, United States

NOT YET RECRUITING

The University of Texas Health Science Center at Houston- McGovern Medical School

Houston, Texas, 77030, United States

RECRUITING

Inova Neurology

Fairfax, Virginia, 22031, United States

RECRUITING

VCU Parkinsons Disease and Movement Disorders Center

Henrico, Virginia, 23233, United States

RECRUITING

MedStar Georgetown University Hospital Department of Neurology

McLean, Virginia, 22101, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Hester Visser, MD

  Amneal Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 9, 2025
• Study Start: February 12, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): August 6, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)