Status and phase
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The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).
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Inclusion 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.
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.
At baseline (Visit 1), review of the 3-day PD diaries confirms the following:
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):
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.
Exclusion criteria
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)
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.
Primary purpose
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Interventional model
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220 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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