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New treatment option for Parkinson Disease
Official title A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
ClinicalTrials.gov ID: NCT06765668
What this study is testing
What is CREXONT ER?
CREXONT ER is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson disease.
Also referred to as IPX203.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with PD consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with...
- Participants with a score of at least 20 units at Screening on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)...
- 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...
- 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.
You likely can't join 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)...
- 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).
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- 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...
- Employees or family members of the investigator, or study site staff, or Sponsor.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Aliso Viejo, California, United States
- Palo Alto, California, United States
- Aventura, Florida, United States
- Boca Raton, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Winfield, Illinois, United States
- Kansas City, Kansas, United States
- Farmington Hills, Michigan, United States
- Las Vegas, Nevada, United States
- Commack, New York, United States
- Winston-Salem, North Carolina, United States
- Canton, Ohio, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Tulsa, Oklahoma, United States
- Dallas, Texas, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Aliso Viejo, California, United States; Palo Alto, California, United States; Aventura, Florida, United States; Boca Raton, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.