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| Name | Class |
|---|---|
| Amneal Pharmaceuticals, LLC | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CREXONT ER | Experimental | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CREXONT ER | Drug | CREXONT ER capsule. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 42 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hester Visser, MD | Amneal Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Not yet recruiting | Phoenix | Arizona | 85013 | United States |
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| University of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
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| Parkinson's Research Centers of America - Orange County | Recruiting | Aliso Viejo | California | 92656 | United States |
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| Parkinson's Research Centers of America - Palo Alto | Recruiting | Palo Alto | California | 94301 | United States |
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| Visionary Investigators Network | Recruiting | Aventura | Florida | 33180 | United States |
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| Parkinsons Disease and Movement Disorders Center of Boca Raton | Recruiting | Boca Raton | Florida | 33486 | United States |
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| Univesity of Miami - Miller School of Medicine | Recruiting | Boca Raton | Florida | 33486 | United States |
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| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| N1 Research LLC | Recruiting | Orlando | Florida | 32825 | United States |
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| USF Parkinson's Disease and Movement Disorders Center | Recruiting | Tampa | Florida | 33613 | United States |
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| Central DuPage Hospital - Movement Disorders Center | Not yet recruiting | Winfield | Illinois | 60190 | United States |
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| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| Quest Research Institute | Recruiting | Farmington Hills | Michigan | 48334 | United States |
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| Cleveland Clinic Lou Ruvo Center for Brain Health | Not yet recruiting | Las Vegas | Nevada | 89106 | United States |
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| Parkinson's Research Centers of America - Long Island | Recruiting | Commack | New York | 11725 | United States |
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| Atrium Health Wake Forest Baptist Adult Neurology - Janeway Tower | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| NeuroScience Research Center, LLC | Recruiting | Canton | Ohio | 44718 | United States |
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| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| The Movement Disorder Clinic of Oklahoma | Recruiting | Tulsa | Oklahoma | 73136 | United States |
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| Neurology Consultants of Dallas, PA | Recruiting | Dallas | Texas | 75243 | United States |
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| Texas Movement Disorder Specialists, PLLC | Recruiting | Georgetown | Texas | 78628 | United States |
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| Icahn School of Medicine at Mount Sinai | Not yet recruiting | Houston | Texas | 77030 | United States |
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| The University of Texas Health Science Center at Houston- McGovern Medical School | Recruiting | Houston | Texas | 77030 | United States |
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| Inova Neurology | Recruiting | Fairfax | Virginia | 22031 | United States |
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| VCU Parkinsons Disease and Movement Disorders Center | Recruiting | Henrico | Virginia | 23233 | United States |
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| MedStar Georgetown University Hospital Department of Neurology | Recruiting | McLean | Virginia | 22101 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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