A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease
Recruiting
Phase 4Interventional Study
Parkinson Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
Impax Laboratories, LLC · Industry
Who this trial is looking for
This trial is looking for participants with Parkinson's disease who have regular 'off' periods where symptoms worsen. Taking part involves evaluating the effects of a medication called CREXONT over a period of time.
Are You a Good Fit for This Trial?
Must be takingCarbidopa-levodopa
Must not be takingDuopaNonselective MAOIApomorphineInhaled levodopa
You may be able to join if
I have Parkinson's disease and follow a stable treatment.
I score at least 20 on the Movement Disorder Society rating scale in the 'Off' state.
I experience predictable 'off' periods during which my symptoms worsen.
I have daily 'wearing-off' episodes affecting my motor symptoms.
I recognize the difference between my 'On' and 'Off' states.
I can complete a 3-day diary of my symptoms with valid entries.
I have been on a stable regimen of oral carbidopa-levodopa for at least 4 weeks.
I can give written consent to participate in this study.
You may not be able to join if
I have had prior surgery for Parkinson's disease.
I have taken certain medications within the last 4 weeks.
I do not understand the study terms or procedures.
I am an employee or family member of the study staff.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
Trial Locations
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Eligibility Criteria
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 - U…
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.
Contacts
No contact information available.
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