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Following everyday use of a longer-acting Parkinson’s medicine

Researchers study the effects and safety of CREXONT, a longer-acting carbidopa and levodopa medicine, in everyday care.

Testing a treatment or activity · Study reference: NCT06765668

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported actual date)
2025-02-12
Main measurements finished (planned)
2025-11
Study finished (planned)
2026-08-06

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 18 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: 1. 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. 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: 1. Participant who, in the opinion of the clinical investigator, should not participate in the study based on the CREXONT Prescribing Information. 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.
Full study name & original research details

Official study title

Open-Label Phase 4 Study of CREXONT® (Carbidopa and Levodopa) Extended Release Capsules in Parkinson's Disease Patients

Short title used by the registry

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

Original description

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 reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
CREXONT ER
Phases
PHASE4
Sponsor
Impax Laboratories, LLC
Start date reported by registry
2025-02-12 (actual)

Registry updated: 2025-08-24 · Status last verified by the registry submitter: 2025-08

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Barrow Neurological Institute

Phoenix, Arizona, United States

Not yet recruiting

Nicki Niemann · 602-406-4280 · MovementResearch@dignityhealth.org

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Recruiting

Rohit Dhall · 501-526-5282 · rdhall@uams.edu

Parkinson's Research Centers of America - Orange County

Aliso Viejo, California, United States

Recruiting

Mindy Bixby · 949-738-1613 · Bixby_research@parkinsonscenter.org

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States

Recruiting

Salima Brillman · 650-394-6690 · info_PaloAlto@parkinsonscenter.org

Visionary Investigators Network

Aventura, Florida, United States

Recruiting

Julie Schwartzbard · 305-933-5993 · DrJ@aventuraneuro.com

Parkinsons Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Recruiting

Stuart Isaacson · 561-392-1818 · info@parkinsonscenter.org

Univesity of Miami - Miller School of Medicine

Boca Raton, Florida, United States

Recruiting

Henry Moore · 561-939-4169 · HMoore@med.miami.edu

University of Miami

Miami, Florida, United States

Recruiting

Jason Margolesky · 305-243-6732 · jhmargolesky@med.miami.edu

N1 Research LLC

Orlando, Florida, United States

Recruiting

Ramon Rodriguez · 407-674-1648 · rodriguez@neurologyone.com

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

Recruiting

Robert Hauser · 813-396-0751 · rhauser@usf.edu

Central DuPage Hospital - Movement Disorders Center

Winfield, Illinois, United States

Not yet recruiting

Martha McGraw · 630-933-4056 · Martha.McGraw@nm.org

University of Kansas Medical Center

Kansas City, Kansas, United States

Recruiting

Angela Richmond · 913-588-7159 · arichmond4@kumc.edu

Quest Research Institute

Farmington Hills, Michigan, United States

Recruiting

Aaron Ellenbogen · 248-957-8940 · aaron@questri.com

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Not yet recruiting

Zoltan Mari · 702-483-6000 · Mariz@ccf.orh

Parkinson's Research Centers of America - Long Island

Commack, New York, United States

Recruiting

David Kreitzman · 631-462-7774 · info_LongIsland@parkinsonscenter.org

Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower

Winston-Salem, North Carolina, United States

Recruiting

Deepal Shah-Zamora · 336-716-4101 · dshahzam@wakehealth.edu

NeuroScience Research Center, LLC

Canton, Ohio, United States

Recruiting

Ryan Drake · 330-244-2542 · rsddo@neurocarecenter.com

University of Cincinnati

Cincinnati, Ohio, United States

Recruiting

Alberto Espay · 513-558-4035 · espayaj@ucmail.uc.edu

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Recruiting

Camilla Kilbane · 216-844-2327 · Camilla.Kilbane@uhhospitals.org

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Recruiting

Kevin Klos · 918-392-4530 · kevin.klos@mdcok.com

Neurology Consultants of Dallas, PA

Dallas, Texas, United States

Recruiting

Nirav Pavasia · 214-750-9977 · npavasia@neurologydallas.com

Texas Movement Disorder Specialists, PLLC

Georgetown, Texas, United States

Recruiting

Michael Soileau · 512-693-4041 · msoileau@txmds.net

Icahn School of Medicine at Mount Sinai

Houston, Texas, United States

Not yet recruiting

Joohi Shahed · 713-798-8655 · joohi.jimenez-shahed@mountsinai.org

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

Houston, Texas, United States

Recruiting

Mya Schiess · 713-500-7121 · Mya.C.Schiess@uth.tmc.edu

Inova Neurology

Fairfax, Virginia, United States

Recruiting

Drew Falconer · 703-845-1500 · drew.falconer@inova.org

VCU Parkinsons Disease and Movement Disorders Center

Henrico, Virginia, United States

Recruiting

Leslie Cloud · 804-356-7521 · Leslie.Cloud@vcuhealth.org

MedStar Georgetown University Hospital Department of Neurology

McLean, Virginia, United States

Recruiting

Fernando Pagan · 757-802-5001 · LL928@georgetown.edu

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.