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The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:
All participants will be given IPX066 for 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label IPX066 | Other | Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPX066 95 mg | Drug | 23.75 - 95 mg CD-LD capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III | Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study. Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25 | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total UPDRS Parts I-IV | Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient. Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25 |
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Inclusion Criteria:
Each subject must meet the following inclusion criteria in order to be enrolled in the study:
Exclusion Criteria:
Each subject must be free of the following exclusion criteria in order to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Impax Study Director | Impax Laboratories, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Mohammed Ali Parkinson's Center |
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Study dates March 25, 2010 through October 19, 2011 Completion of previous trial a requirement
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| ID | Title | Description |
|---|---|---|
| FG000 | IPX066 | Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| IPX066 145 mg | Drug | 36.25 - 145 mg CD-LD capsules |
|
|
| IPX066 195 mg | Drug | 48.75 - 195 mg CD-LD capsules |
|
|
| IPX066 245 mg | Drug | 61.25 - 245 mg CD-LD capsules |
|
|
| 9 months |
| Patient Global Impression (PGI) | Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start | 9 months |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States |
| Clinical Trials Inc. | Little Rock | Arkansas | 72205 | United States |
| Coastal Neurological Medical Group | La Jolla | California | 92037 | United States |
| Coordinated Clinical Research | La Jolla | California | 92037 | United States |
| The Parkinson's Institute | Sunnyvale | California | 94085 | United States |
| Collaborative NeuroScience Network, Inc. | Torrance | California | 90502 | United States |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | United States |
| Sunrise Clinical Research | Hollywood | Florida | 33021 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida | Port Charlotte | Florida | 33980 | United States |
| Suncoast Neuroscience Associates, Inc. | St. Petersburg | Florida | 33713 | United States |
| University of South Florida, Parkinson's Disease and Movement Disorders Center | Tampa | Florida | 33603 | United States |
| Medical College of Georgia, Movements Disorders Clinic | Augusta | Georgia | 30912 | United States |
| Movement Disorder Center at Idaho Elks Rehabilitation Hospital | Boise | Idaho | 83702 | United States |
| Northwestern University, Feinberg School of Medicine, Dept. of Neurology | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Quest Research Institute | Bingham Farms | Michigan | 48025 | United States |
| Struthers Parkinson's Center | Golden Valley | Minnesota | 55427 | United States |
| UMDNJ Robert Wood Johnson Medical Center, Department of Neurology | New Brunswick | New Jersey | 08901 | United States |
| Albany Medical College, Parkinson's Disease and Movement Disorders Center | Albany | New York | 12208 | United States |
| David L. Kreitzman, MD, P.C. | Commack | New York | 11725 | United States |
| Columbia University Neurological Institute | New York | New York | 10032 | United States |
| Institute for Human Performance | Syracuse | New York | 13210 | United States |
| Duke University Medical Center Movement Disorders Center | Durham | North Carolina | 27707 | United States |
| University Neurology, Inc. | Cincinnati | Ohio | 45219 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| The Movement Disorder Clinic of Oklahoma | Tulsa | Oklahoma | 74136 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9184 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| South Puget Sound Neurology | Tacoma | Washington | 98405 | United States |
| Wisconsin Institute for Neurologic and Sleep Disorders | Milwaukee | Wisconsin | 53233 | United States |
| London Health Sciences Centre, University Hospital | London | Ontario | N6A 5A5 | Canada |
| Parkinson's & Neurodegenerative Disorder Clinic | Ottawa | Ontario | K1G 4G3 | Canada |
| Ottawa Hospital Civic Site | Ottawa | Ontario | K1Y 4E9 | Canada |
| Quebec Memory & Motor Skills Disorders Clinic | Québec | Quebec | G1R 3X5 | Canada |
| East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| West Tallinn Central Hospital, | Tallinn | 10617 | Estonia |
| Praxis für Neurologie und Psychiatrie | Westerstede | Lower Saxony | 26655 | Germany |
| Neurozentrm - Praxis fur Neurologie und Psychiatrie | Berlin | 10437 | Germany |
| Neurologiepraxis | Berlin | 12163 | Germany |
| P.Stradina university hospital | Riga | 1002 | Latvia |
| Gailezers hospital | Riga | Latvia |
| Kaunas Medical University Hospital | Kaunas | LT-50009 | Lithuania |
| Siauliai Regional Hospital | Šiauliai | LT-76231 | Lithuania |
| National Centre of Osteoporosis | Vilnius | LT-01102 | Lithuania |
| Vilnius University Emergency Hospital | Vilnius | LT-04130 | Lithuania |
| Vilnius University Hospital Santariskiu klinikos | Vilnius | LT-08661 | Lithuania |
| PALLMED Sp. z o.o. | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Krakowska Akademia Neurologii Sp. z o. o. | Krakow | Lesser Poland Voivodeship | 31-530 | Poland |
| Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie | Lublin | Lublin Voivodeship | 20-718 | Poland |
| Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A. | Warsaw | Masovian Voivodeship | 02-777 | Poland |
| Euromedis Sp. z o.o. | Szczecin | West Pomeranian Voivodeship | 70-215 | Poland |
| Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska | Mosina | Wielkopoloskie | 62-050 | Poland |
| Neuro-Care NZOZ | Katowice | 40-546 | Poland |
| Clinical Rehabilitation Hospital Iasi, Neurology Department | Lasi | Romania | 700661 | Romania |
| Psychiatry and Neurology Hospital Brasov, Neurology Department | Brasov | 500123 | Romania |
| Neomed Research | Brasov | 500283 | Romania |
| Colentina Clinical Hospital Bucharest, II Neurology Department | Bucharest | 020125 | Romania |
| CFR Clinical Hospital Constanta, Neurology Department | Constanța | 900123 | Romania |
| County Clinical Emergency Hospital Targu Mures, I Neurology Department | Târgu Mureş | 540136 | Romania |
| County Clinical Emergency Hospital Targu Mures, II Neurology Department | Târgu Mureş | 540136 | Romania |
| County Clinical Emergency Hospital Timisoara, Neurology Department | Timișoara | 300736 | Romania |
| Hospital General de Cataluña | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Clinica Ruber SA | Madrid | 28006 | Spain |
| Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov | Dnipropetrovsk | 49005 | Ukraine |
| Department of Psychiatry and Medical Psychology of Donetsk National Medical University | Donetsk | 83037 | Ukraine |
| Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University | Donetsk | 83099 | Ukraine |
| 1st neurology department of Central Clinical Hospital of Ukrzaliznytsya | Kharkiv | 61058 | Ukraine |
| Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine | Kharkiv | 61068 | Ukraine |
| Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine | Kharkiv | 61068 | Ukraine |
| Neurology department of Lviv regional clinical hospital | Lviv | 79010 | Ukraine |
| Odessa Regional Clinical Hospital, Dept. of Neurosurgery | Odesa | 65025 | Ukraine |
| Neurology department of Medical Dental Academy based on Poltava regional hospital | Poltava | 36000 | Ukraine |
| Vinnytsia Regional Psycho-Neurological Hospital | Vinnytsia | 21005 | Ukraine |
| Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6 | Zaporizhzhya | 69035 | Ukraine |
| Zaporozhye Regional Clinical Hospital | Zaporizhzhya | 69600 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | IPX066 | Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change From Baseline in the Sum of UPDRS Part II + UPDRS Part III | Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) + UPDRS Part III (Motor Examination) at End of Study. Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25 | All enrolled subjects with available data | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Total UPDRS Parts I-IV | Analysis of the Change from Baseline in the sum of the Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living), UPDRS Part III (Motor Examination), and Part IV (Complications of Therapy [In the past week]) at End of Study. Includes both scoring by a clinician and a historical report of mental functioning, activities of daily living and complications of therapy in the past week obtained by questioning the patient. Unified Parkinson's Disease Rating Scale (UPDRS) - Four Parts Higher score values represent a worse outcome. Subscales II and III were summed: Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16 Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25 | All enrolled subjects with available data | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
| ||||||||||||||||||||||||||
| Secondary | Patient Global Impression (PGI) | Satisfaction of IPX066 using Patient Global Impression (PGI) 7-point scale. Patient Global Impression 0-7 - higher value indicates increased improvement from study start | All enrolled subjects with available data | Posted | Mean | Standard Deviation | units on a scale | 9 months |
|
|
Screening through 9 months
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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 | IPX066 | Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study. | 43 | 617 | 122 | 617 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pancreatitis haemorrhagic | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Femur facture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Scalpula fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Freezing phenomenon | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pelvic prolapse | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Toe operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
Publication of the results of the Study conducted at the Site shall not be made before the first multi-site publication by Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daven Mody, PharmD, MBA, Director, Regulatory Affairs | Impax Laboratories, Inc. | 510-240-6073 | dmody@impaxlabs.com |
| 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
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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| Unknown or Not Reported |
|
| Asian |
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| Other |
|
| Romania |
|
| United States |
|
| Ukraine |
|
| Poland |
|
| Lithuania |
|
| Germany |
|
| Estonia |
|
| Spain |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|