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Parkinson DiseasePhase 4NCT06765668

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

A Phase 4 study testing CREXONT ER in people with Parkinson Disease, run by Impax Laboratories, LLC at 27 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
CREXONT ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
27 sitesUnited States
Study dates
12 Feb 2025to 6 Aug 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 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.
  • 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:
  • 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.
  • 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.
  • Participant is able and willing to provide written informed consent prior to the conduct of any study-specific procedures.
  • 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.
  • Participants who have participated in prior CREXONT clinical studies are allowed to be enrolled in this Phase 4 study.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

27 sites in 1 country

United States27 sites, 27 recruiting

  • Parkinson's Research Centers of America - Orange County

    Aliso Viejo, California, 92656

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

    Recruiting

  • Visionary Investigators Network

    Aventura, Florida, 33180

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

    Recruiting

  • Parkinsons Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

    Stuart Isaacson, 561-392-1818 ext. 2, info@parkinsonscenter.org

    Recruiting

  • Univesity of Miami - Miller School of Medicine

    Boca Raton, Florida, 33486

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

    Recruiting

  • NeuroScience Research Center, LLC

    Canton, Ohio, 44718

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

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

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

    Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

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

    Recruiting

  • Parkinson's Research Centers of America - Long Island

    Commack, New York, 11725

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

    Recruiting

  • Neurology Consultants of Dallas, PA

    Dallas, Texas, 75243

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

    Recruiting

  • Inova Neurology

    Fairfax, Virginia, 22031

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

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

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

    Recruiting

  • Texas Movement Disorder Specialists, PLLC

    Georgetown, Texas, 78628

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

    Recruiting

  • VCU Parkinsons Disease and Movement Disorders Center

    Henrico, Virginia, 23233

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

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    Houston, Texas, 77030

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

    Not yet recruiting

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

    Houston, Texas, 77030

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

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

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

    Recruiting

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

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

    Not yet recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

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

    Recruiting

  • MedStar Georgetown University Hospital Department of Neurology

    McLean, Virginia, 22101

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

    Recruiting

  • University of Miami

    Miami, Florida, 33136

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

    Recruiting

  • N1 Research LLC

    Orlando, Florida, 32825

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

    Recruiting

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, California, 94301

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

    Recruiting

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

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

    Not yet recruiting

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida, 33613

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

    Recruiting

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 73136

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

    Recruiting

  • Central DuPage Hospital - Movement Disorders Center

    Winfield, Illinois, 60190

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

    Not yet recruiting

  • Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower

    Winston-Salem, North Carolina, 27157

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

    Recruiting

Other trials in United States

About this study

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

The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).

Being tested
CREXONT ER
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CREXONT ERDrug

    Also called IPX203

    CREXONT ER capsule.

Study groups in NCT06765668
Study groupRoleWhat they receive
CREXONT ERExperimentalParticipants 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.
Receives: Drug: CREXONT ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Day 42

Secondary outcomes (1)

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

    "OFF" time is derived from the 3-day PD diaries. For each day, "OFF" time is calculated by adding the number of half-hour intervals in which the status "Off" is checked.

    Measured: Baseline, Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2025
  2. Study start12 Feb 2025
  3. Primary completionNov 2025 (estimated)
  4. Study completion6 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06765668
Sponsor's protocol ID
IPX203-401-23
Status last verified
Aug 2025
First submitted
31 Dec 2024
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CREXONT ER in people with Parkinson Disease, run by Impax Laboratories, LLC at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in "GOOD ON" time per the Parkinson's Disease Diary to Day 42 (time frame: Baseline, Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06765668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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