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This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVT-301 Low Dose | Experimental | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration |
|
| CVT-301 High Dose | Experimental | Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-301 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Safety of CVT-301 Change From Baseline for FEV1. | To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients. | Change from baseline at 52 weeks |
| Pulmonary Safety for CVT-301 Change From Baseline for FVC. | To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients. | Change from baseline at 52 weeks |
| Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC). | To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients. | Change from baseline at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes. | Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment). | At Treatment Visit - TV6 (Week 52) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Oh, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acorda Site #5020 | Scottsdale | Arizona | 85259 | United States | ||
| Acorda Site #5042 |
Not provided
| Label | URL |
|---|---|
| Click here for more information about this study:CVT-301-004E | View source |
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Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | CVT-301 Low Dose | Two capsules of 30 mg each (60 mg total) of levodopa inhalational powder orally inhaled up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
| FG001 | CVT-301 High Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 7, 2016 | Jun 12, 2019 |
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| Change From Baseline in OFF Time. | Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home. | Change from baseline through 12 months duration of outpatient use |
| Fresno |
| California |
| 93710 |
| United States |
| Acorda Site #5064 | Fullerton | California | 92835 | United States |
| Acorda Site #5035 | Loma Linda | California | 92354 | United States |
| Acorda Site #5027 | Long Beach | California | 90806 | United States |
| Acorda Site #5037 | Los Angeles | California | 90033 | United States |
| Acorda Site #5070 | Pasadena | California | 91105 | United States |
| Acorda Site #5047 | Reseda | California | 91335 | United States |
| Acorda Site #5068 | Santa Ana | California | 92705 | United States |
| Acorda Site #5069 | Torrance | California | 90505 | United States |
| Acorda Site #5052 | Washington D.C. | District of Columbia | 20007 | United States |
| Acorda Site #5046 | Atlantis | Florida | 33462 | United States |
| Acorda Site #5053 | Aventura | Florida | 33180 | United States |
| Acorda Site #5013 | Boca Raton | Florida | 33486 | United States |
| Acorda Site #5016 | Jacksonville | Florida | 32209 | United States |
| Acorda Site #5071 | Maitland | Florida | 32751 | United States |
| Acorda Site #5044 | Orlando | Florida | 32806 | United States |
| Acorda Site #5060 | Palm Beach Gardens | Florida | 33410 | United States |
| Acorda Site #5001 | Port Charlotte | Florida | 33952 | United States |
| Acorda Site #5065 | St. Petersburg | Florida | 33713 | United States |
| Acorda Site #5012 | Tampa | Florida | 33613 | United States |
| Acorda Site #5040 | Atlanta | Georgia | 30329 | United States |
| Acorda Site #5025 | Chicago | Illinois | 60611 | United States |
| Acorda Site #5030 | Chicago | Illinois | 60612 | United States |
| Acorda Site #5011 | Elk Grove Village | Illinois | 60007 | United States |
| Acorda Site #5003 | Kansas City | Kansas | 66160 | United States |
| Acorda Site #5067 | Baton Rouge | Louisiana | 70810 | United States |
| Acorda Site #5057 | Baltimore | Maryland | 21201 | United States |
| Acorda Site #5056 | Boston | Massachusetts | 02114 | United States |
| Acorda Site #5018 | Boston | Massachusetts | 02118 | United States |
| Acorda Site #5002 | Bingham Farms | Michigan | 48025 | United States |
| Acorda Site #5014 | West Bloomfield | Michigan | 48322 | United States |
| Acorda Site #5041 | Golden Valley | Minnesota | 55427 | United States |
| Acorda Site #5006 | St Louis | Missouri | 63110 | United States |
| Acorda Site #5023 | Las Vegas | Nevada | 89102 | United States |
| Acorda Site #5028 | Albany | New York | 12208 | United States |
| Acorda Site #5039 | Brooklyn | New York | 11203 | United States |
| Acorda Site #5031 | New York | New York | 10016 | United States |
| Acorda Site #5032 | New York | New York | 10029 | United States |
| Acorda Site #5004 | New York | New York | 10032 | United States |
| Acorda Site #5038 | Syracuse | New York | 13210 | United States |
| Acorda Site #5048 | Charlotte | North Carolina | 28204 | United States |
| Acorda Site #5005 | Cleveland | Ohio | 44195 | United States |
| Acorda Site #5050 | Norwood | Ohio | 45212 | United States |
| Acorda Site #5062 | Portland | Oregon | 97239 | United States |
| Acorda Site #5036 | Allentown | Pennsylvania | 18103 | United States |
| Acorda Site #5010 | Philadelphia | Pennsylvania | 19107 | United States |
| Acorda Site #5058 | Willow Grove | Pennsylvania | 19090 | United States |
| Acorda Site #5022 | Charleston | South Carolina | 29425 | United States |
| Acorda Site #5029 | Nashville | Tennessee | 372322551 | United States |
| Acorda Site #5019 | Houston | Texas | 77030 | United States |
| Acorda Site #5045 | Houston | Texas | 77030 | United States |
| Acorda Site #5049 | Henrico | Virginia | 23226 | United States |
| Acorda Site #5059 | Virginia Beach | Virginia | 23456 | United States |
| Acorda Site #5051 | Kirkland | Washington | 98034 | United States |
| Acorda Site #5103 | London | Ontario | N6A5A5 | Canada |
| Acorda Site #5104 | Ottawa | Ontario | K1Y4E9 | Canada |
| Acorda Site #5105 | Toronto | Ontario | M5T2S8 | Canada |
| Acorda Site #5201 | Prague | 10000 | Czechia |
| Acorda Site #5203 | Prague | 14000 | Czechia |
| Acorda Site #5305 | Gdansk | Zappa | 80462 | Poland |
| Acorda Site #5304 | Katowice | 40588 | Poland |
| Acorda Site #5306 | Krakow | 30349 | Poland |
| Acorda Site #5303 | Krakow | 30510 | Poland |
| Acorda Site #5307 | Krakow | 31505 | Poland |
| Acorda Site #5302 | Lodz | 90130 | Poland |
| Acorda Site #5308 | Warsaw | 00453 | Poland |
| Acorda Site #5301 | Warsaw | 01868 | Poland |
| Acorda Site #5407 | Pamplona | Navarre | 31008 | Spain |
| Acorda Site #5404 | Barcelona | 08026 | Spain |
| Acorda Site #5406 | Barcelona | 08035 | Spain |
| Acorda Site #5405 | Madrid | 28006 | Spain |
| Acorda Site #5403 | San Sebastián | 20009 | Spain |
| Acorda Site #5401 | Sant Cugat del Vallès | 08190 | Spain |
Two capsules of 42 mg each (84 mg total) of levodopa inhalational powder orally inhaled up to 5 times/day for OFF episodes for 12 months duration
CVT-301
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics of 312 is based on the Safety Population of 325 participants randomized less 13 who were randomized and Not Dosed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CVT-301 Low Dose | 60 mg (two capsules of 30 mg) of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
| BG001 | CVT-301 High Dose | 84 mg (two capsules of 42 mg) of levodopa inhalational powder used up to 5 times/day for OFF episodes for 12 months duration CVT-301 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Pulmonary Safety of CVT-301 Change From Baseline for FEV1. | To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients. | Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug. | Posted | Mean | Standard Deviation | Liters | Change from baseline at 52 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | Pulmonary Safety for CVT-301 Change From Baseline for FVC. | To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients. | Safety Population - Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug. | Posted | Mean | Standard Deviation | Liter | Change from baseline at 52 weeks |
| ||||||||||||||||||||||||||||||
| Primary | Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC). | To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients. | Safety Population - Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug. | Posted | Mean | Standard Deviation | Ratio % | Change from baseline at 52 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes. | Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment). | ITT (Intent-to-Treat) Population | Posted | Count of Participants | Participants | At Treatment Visit - TV6 (Week 52) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in OFF Time. | Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An "OFF state" is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home. | ITT - (Intent-to-Treat) Population. Patients who discontinue the study prior to a treatment visit are not included in the analysis for that treatment visit. Therefore, the number of patients decreases with each successive treatment visit. | Posted | Least Squares Mean | Standard Error | Hours | Change from baseline through 12 months duration of outpatient use |
|
|
12-month period
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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 | CVT-301 Low Dose | 60 mg (two capsules of 30 mg each) of Levodopa Inhalational Powder (LIP) up to 5 times a day for OFF episodes for 12 months duration. | 0 | 153 | 22 | 153 | 81 | 153 |
| EG001 | CVT-301 HIgh Dose | 84 mg (two capsules of 42 mg each) of Levodopa inhalation powder (LIP) up to 5 times a day for OFF episodes for 12 months duration. | 0 | 159 | 13 | 159 | 69 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mycardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Megacolon | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Naseau | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomititng | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Necrotising soft tissue infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Prostrate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Prostrate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Device connection tissue | Product Issues | MedDRA 20.1 | Systematic Assessment |
| |
| Impulse-control disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Suicide threat | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bone graft | Surgical and medical procedures | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Oh, Senior Vice President - Clinical Development | Acorda Therapeutics | 914-326-5455 | coh@acorda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2017 | Jun 12, 2019 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Poland |
|
| Spain |
|
| United States |
|
| TV3 (Week 12) |
|
|
| TV4 (Week 24) |
|
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| TV5 (Week 36) |
|
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| TV6 (Week 52) |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
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