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Primary Objective:
To compare the pharmacokinetics (PK) of single and multiple doses of IPX203 with Immediate release carbidopa-levodopa (IR CD-LD) in subjects with advanced Parkinson's disease (PD).
Secondary Objectives:
To compare the pharmacodynamics of single and multiple doses of IPX203 with IR CD-LD.
To compare the efficacy of IPX203 with IR CD-LD following multiple doses.
To evaluate the safety of IPX203.
IPX203 is an investigational product containing CD-LD.
IPX203-B16-01 Study Design:
A randomized, open-label, rater-blinded, multicenter, 2-treatment, 2-period, multiple-dose crossover study.
Approximately 30 qualified IR CD-LD-experienced advanced PD subjects will be randomized.
The study duration will be approximately 8 weeks, including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPX203 then Sinemet | Experimental | Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablet for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours. |
|
| Sinemet then IPX203 | Experimental | Participants first received Sinemet Capsules for 15 days After a Washout Period of 7 days; participants then received IPX203 ER CD-LD Capsules for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinemet | Drug | Immediate Release Tablet containing carbidopa-levodopa flexible dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Levodopa Cmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Levodopa Tmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Levodopa t1/2 Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Levodopa AUCt Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Levodopa AUCinf Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Carbidopa Cmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
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Eligibility will be determined at screening and Visit 1 of the study.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Impax Study Director | Impax Laboratories, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator 110 | Little Rock | Arkansas | 72205 | United States | ||
| Site 114 |
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28 of 39 subjects were enrolled and randomized
A total of 39 subjects were screened at 10 study sites between November 8, 2016 and August 1, 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | IPX203 First Then Sinemet | Participants first received IPX203 ER CD-LD Capsules for 15 days After a Washout Period of 7 days; participants then received Sinemet (IR CD-LD) Tablets for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2016 | Apr 30, 2021 |
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| IPX203 | Drug | Extended Release capsules containing carbidopa-levodopa flexible dosing |
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| Carbidopa Tmax Following First Dose on Day 1 |
Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose |
| Day 1 |
| Carbidopa t1/2 Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Carbidopa AUCt Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Carbidopa AUCinf Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Day 1 |
| Levodopa Cmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Day 15 |
| Levodopa Tmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Day 15 |
| Levodopa AUCtau Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Day 15 |
| Carbidopa Cmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Day 15 |
| Carbidopa Tmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Day 15 |
| Carbidopa AUCtau Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Day 15 |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Investigator 106 | Boca Raton | Florida | 33486 | United States |
| Investigator 112 | Naples | Florida | 34102 | United States |
| Investigator 113 | Port Charlotte | Florida | 33980 | United States |
| Site 108 | Tampa | Florida | 33613 | United States |
| Investigator 101 | Farmington Hills | Michigan | 48334 | United States |
| Site 103 | Durham | North Carolina | 27705 | United States |
| Investigator 109 | Cleveland | Ohio | 44106 | United States |
| Site 115 | Kirkland | Washington | 98034 | United States |
| Investigator 104 | Spokane | Washington | 99202 | United States |
| FG001 |
| Sinemet First Then IPX203 |
Participants first received Sinemet for 15 days After a Washout Period of 7 days; participants then received IPX203 for 15 days Study drug doses were determined based on the subject's prestudy IR CD-LD regimen The typical IPX203 dosing regimen was 3 times a day, dosed approximately every 7 to 8 hours. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout (7 Days) |
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| Second Interventions (14 Days) |
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Subjects who were enrolled and randomized to 1 of 2 treatment sequences
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | The recommended first morning dose of IPX203 on Day 1 was based on the subject's prestudy IR CD-LD morning dose The initial IR CD-LD dosing regimen was the same as the subject's stable prestudy regimen (unless s/he was taking a single daily bedtime dose of CR CD-LD, either alone or in combination with IR CD-LD, in which case, the CR CD-LD dose was discontinued and substituted with a 1:1 milligram-equivalent IR CD-LD dose). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Age at Parkinson's disease onset | Mean | Standard Deviation | years |
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| Duration of Parkinson's disease | Mean | Standard Deviation | years |
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| Hoehn and Yahr Score | 0:Asymptomatic
| Count of Participants | Participants |
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| Montreal Cognitive Assessment Score (On State) | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. it assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal. Montreal Cognitive Assessment (MoCA) score ≥ 24 is required at Screening Visit in "on" state. | Count of Participants | Participants |
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| Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while On | MDS-UPDRS Part III was administered pre-dose (baseline). It comprises 18 items (speech,facial expression,rigidity,finger tapping,hand movements,pronation-supination hand movements,toe tapping,leg agility,arising from chair,gait,freezing of gait,postural stability,posture,global spontaneity movement, postural tremor of hands,kinetic tremor of hands,rest tremor amplitude,constancy of rest tremor scored on a 5-point normal-to-severe scale including dyskinesia impact questions ranging from 0 to 90 points. The higher the score the more abnormality. | Mean | Standard Deviation | units on a scale |
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| Movement Disorder Society version of the Unified Parkinson's Disease Rating Scale Part III while Off | MDS-UPDRS Part III was administered pre-dose (baseline). It comprises 18 items (speech,facial expression,rigidity,finger tapping,hand movements,pronation-supination hand movements,toe tapping,leg agility,arising from chair,gait,freezing of gait,postural stability,posture,global spontaneity movement, postural tremor of hands,kinetic tremor of hands,rest tremor amplitude,constancy of rest tremor scored on a 5-point normal-to-severe scale including dyskinesia impact questions ranging from 0 to 90 points. The higher the score the more abnormality. | Mean | Standard Deviation | units on a scale |
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| Total "off" time from subject diary | Mean | Standard Deviation | hours |
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| Total Good "on" time from subject diary | Mean | Standard Deviation | hours |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Levodopa Cmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng/mL | Day 1 |
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| Primary | Levodopa Tmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | hour | Day 1 |
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| Primary | Levodopa t1/2 Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | hour | Day 1 |
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| Primary | Levodopa AUCt Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 |
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| Primary | Levodopa AUCinf Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 |
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| Primary | Levodopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | Percentage | Day 1 |
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| Primary | Carbidopa Cmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng/mL | Day 1 |
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| Primary | Carbidopa Tmax Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | hour | Day 1 |
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| Primary | Carbidopa t1/2 Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | hour | Day 1 |
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| Primary | Carbidopa AUCt Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 |
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| Primary | Carbidopa AUCinf Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng.h/mL | Day 1 |
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| Primary | Carbidopa Bioavailability Relative to IR CD/LD Following First Dose on Day 1 | Single Dose predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, and 8 hours postdose | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | Percentage | Day 1 |
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| Primary | Levodopa Cmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng/mL | Day 15 |
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| Primary | Levodopa Tmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | hour | Day 15 |
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| Primary | Levodopa AUCtau Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng.h/ML | Day 15 |
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| Primary | Carbidopa Cmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng/mL | Day 15 |
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| Primary | Carbidopa Tmax Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | hour | Day 15 |
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| Primary | Carbidopa AUCtau Following First Dose on Day 15 | Multiple Dose predose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, and 10 hours postdose. | Randomized subjects who completed both periods | Posted | Mean | Standard Deviation | ng.h/mL | Day 15 |
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15 days for each intervention plus 1 week washout up to a total of 37 days
All 28 subjects received at least one dose of IPX203 and 27 subjects received at least one dose of IR CD-LD
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IPX203 | Participants received IPX203 ER CD-LD Capsules | 0 | 28 | 1 | 28 | 10 | 28 |
| EG001 | Sinemet | Participant received Sinemet (IR CD-LD) Tablets | 0 | 27 | 0 | 27 | 2 | 27 |
| EG002 | Washout Period | Washout between Period 1 and Period 2 | 0 | 28 | 1 | 28 | 0 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhorea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Upper respiratiory track infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Urinary Tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Occipital Neuralgia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Confusional State | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Orthostatic Hypertension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Fitzpatrick, Director, Specialty Regulatory Affairs | Impax Laboratories, LLC | 631-633-2104 | pfitzpatrick@amneal.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2017 | Apr 30, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| III |
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| IV |
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| MoCA score 26 to <28 |
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| MoCA score 28 to <30 |
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| 30 |
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