Back to resultsStudy Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment (TEAL)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AKST4290
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Parkinson's Disease, Dementia, Movement Disorder, Shaking Palsy
Eligibility Criteria
Key Inclusion Criteria:
- Diagnosis of clinically established or clinically probable PD according to MDS-PD criteria with at least 1 year of PD symptoms.
- Modified Hoehn and Yahr ≤2.5.
- Have notable motor worsening during off-medication state.
- Clear-cut improvement of motor response to levodopa medications, as assessed by the investigator.
- Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at least 8 weeks prior to enrollment and remain on stable dose during the 12-week treatment period.
- Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use highly effective contraception prior to study entry. Male subjects must be willing to use a barrier method of contraception.
Key Exclusion Criteria:
- Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body dementia.
- History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant).
- Conditions affecting the peripheral or central nervous system, unless related to PD, that would affect the ability to adequately perform the MDS-UPDRS and motor assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke affecting motor or gait function.
- Significant alcohol or drug abuse within past 2 years.
- Based on ECG reading, subjects with a risk of QT prolongation.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Atlanta Center for Medical Research
- Henry Ford Hospital West Bloomfield
- Movement Disorder Clinic of Oklahoma PLLC
- AS Ida-Tallinna Keskhaigla / East Tallinn Central Hospital
- Astra Kliinik / Astra Team Clinic
- Universitätsklinikum Carl Gustav Carus an der TU Dresden
- Krankenhaus Agatharied GmbH
- Paracelsus-Elena-Klinik Kassel
- Universitatsklinikum Leipzig
- UKGM Marburg
- Klinikum rechts der Isar der Technischen Universität München
- Universitätsklinikum Tübingen
- Universitätsklinikum Ulm
- Centrum Medyczne PRATIA/ Medical Center PRATIA
- Krakowska Akademia Neurologii/ Cracow Academy of Neurology
- Instytut Zdrowia Dr Boczarska-Jedynak Spolka Z Oraganiczona Odpowiedzialnoscia Spolka Komandytowa/ Institute of Health dr Boczarska-Jedynak
- Medicome SP. ZO. O./ Medicome
- Neurologiczny Nzoz Centrum Leczenia Sm Osrodek Badan Klinicznych
- Euro-Neuro, s.r.o., Neurologická ambulancia
- Nemocnica Kramáre II. Neurologická klinika LF UK a UNB /2nd Dept. Of Neurology, Comenius University Faculty of Medicine and University Hospital Bratislava
- Nemocnica s poliklinikou Sv. Lukáša Galanta, a. s Neurologické oddelenie /Neurology Dpt., NsP Galanta
- Univerzitná nemocnica Martin Neurologická klinika/University hospital Martin, Clinic of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AKST4290
Placebo
Arm Description
Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks.
Subjects will receive placebo, twice daily, for 12 weeks.
Outcomes
Primary Outcome Measures
Change in Motor Function During Levodopa Withdrawal.
Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 Motor Examination has 33 scores based on 18 questions with several right, left, or both body distribution scores. Each Parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The minimum score on the MDS-UPDRS Part 3 is 0 and the maximum is 132.
Outcome is the mean change from Baseline in motor function during the practically defined off-medication state, defined as at least 12 hours off levodopa, at Week 12, with lower score representing better outcome.
Secondary Outcome Measures
Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs, grouped by severity, relationship to study treatment, and AEs leading to discontinuation of study participation. Incidence was presented as number of subject with TEAEs and serious TEAEs, grouped by severity, relationship to study treatment, and AEs leading to discontinuation of study participation, throughout study duration.
Evaluation of Laboratory Changes.
Incidence of of abnormalities or clinically significant changes from Baseline in laboratory test data (chemistry, hematology, coagulation, and urinalysis). Incidence was presented as number of subjects abnormal labs indicating serious condition occurred within the analysis population throughout study duration.
Evaluation of Vital Sign Changes.
Incidence of abnormalities or clinically-significant changes from Baseline in Vital sign measurements (blood pressure as measured in mmHg, heart rate as measured in beats per minute, and temperature as measured in degrees Fahrenheit or Celsius). Incidence was presented as number of subjects with abnormalities or clinically-significant changes from Baseline in Vital sign measurements within the analysis group throughout study duration.
Evaluation of Electrocardiogram Changes.
Incidence of abnormalities or clinically-significant changes from Baseline in 12-lead electrocardiogram (ECG) QT-interval. Incidence was presented as number of subject with ECG changes throughout study duration.
The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, Change From Baseline During the On-medication State.
The MDS-UPDRS has 4 components (details below). The rating for each item is from 0 (normal) to 4 (severe). The score for each Part is obtained from the sum of the corresponding item scores, with higher scores indicating more severe impairment.
Part I, Non-Motor Aspects (Mentation, Behavior, and Mood) of Experiences of Daily Living (13 items), score range is 0-52.
Part II, Motor Aspects of Experiences of Daily Living (13 items), score range is 0-52.
Part III, Motor Examination (33 items), score range is 0-132. Part IV, Motor Complications (6 items), score range is 0-24. The outcome is the mean change from Baseline motor function during the on-medication state at Week 12, with lower value representing a better outcome.
The Montreal Cognitive Assessment (MoCA), Change From Baseline in MoCA During the On-medication State.
The Montreal Cognitive Assessment (MoCA) is a neuropsychological tool that requires approximately 15 minutes to assess the following domains: attention, executive function, memory, language, visuoconstructional skills, and orientation. MoCA scores range between 0 and 30, with higher scores indicating more intact cognition.
The MoCA is administered at Baseline and Week 12 in the on-medication state. The total score will be summarized at each scheduled time point.
The outcome is mean change from baseline in MoCA during the on-medication state at Week 12, with higher value representing a better outcome.
The Schwab and England Activities of Daily Living (SE-ADL) Scale, Change From Baseline in SE-ADL During the On-medication State.
The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. Scores will be summarized descriptively at each scheduled time point (i.e. n, %) by treatment group. A Generalized Estimating Equations (GEE) for alternating logistic regression (ALR) with an exchangeable working correlation structure will be employed to analyze change from baseline.
Outcome is mean change from baseline in SE-ADL during the on-medication state at Week 12, with higher values represents a better outcome.
The Clinical Impression of Severity Index - PD (CISI-PD), Change From Baseline in CISI-PD During the On-medication State.
The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled). A total score is calculated by summing the item scores, total scores range from 0-24. The outcome is the mean change from baseline in CISI-PD during the on-medication state at Week 12, with lower score represents a better outcome.
The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), Change From Baseline in PDQ-39 During the On-medication State.
The PDQ-39 is a patient-reported outcome of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. The eight dimensions include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. It is scored on a scale of 0-100 with lower scores indicating better health and high scores indicating more severe symptoms, applying to all dimensions reported in the data table.
Outcome is the mean change from baseline in PDQ-39 during the on-medication state at Week 12, with lower score represents a better outcome.
The Sheehan-Suicidality Tracking Scale (S-STS), Change From Baseline in S-STS During the On-medication State.
The standard version of the S-STS is a 16-item scale that assesses the seriousness of suicidality phenomena on a Likert-type scale (0-4) ranging from "not at all" (0) to "extremely" (4), where higher scores indicate more risk of suicidality. It also assesses the frequency of key phenomena and the overall time spent in suicidality. Total score is a sum of all items; total score ranges from 0-64.
Outcome is the mean change from baseline in S-STS during the on-medication state at Week 12, with higher score represents a worse outcome.
10-meter Timed Walk, Change in Baseline 10-meter Timed Walk During the on and Off-medication State
The 10-meter walk test is a commonly used tool for assessing gait speed in individuals with gait limitations. Gait speed is positively correlated with the amount of community ambulation and quality of life, and it is an important measure of mobility in individuals with PD, with higher value corresponds to better mobility.
Outcome is the mean change from baseline comfortable walking speed (gait), fast walking speed (gait), during the on and off-medication state at Week 12, with higher score represents a better outcome.
Hauser 3-Day Patient Diary, Change in Baseline Mean Time Spent With and Without Troublesome Dyskinesia as Measured by the Hauser 3-Day Patient Diary
The Hauser Patient Diary was developed to assess functional status over a period of time in patients with motor fluctuations and dyskinesia by recording patient motor state for half-hour intervals over a 24-hour period. The outcome is mean change of Mean Time Spent with and without troublesome dyskinesia from Baseline at Week 12.
ON/OFF-time is time when medication is providing/not providing benefit with regard to mobility, slowness, and stiffness, respectively.
Troublesome dyskinesia is defined as dyskinesia that interfere with function or causes meaningful discomfort. Bad time is defined as the sum of off time and on time with troublesome dyskinesia. Lower value represents a better outcome. Good time is defined as the on time without dyskinesia plus on time with non-troublesome dyskinesia. Higher value represents a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04369430
Brief Title
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Acronym
TEAL
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkahest, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's Disease who are currently on stable dopaminergic treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders, Parkinson's Disease, Dementia, Movement Disorder, Shaking Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AKST4290
Arm Type
Experimental
Arm Description
Subjects will receive AKST4290, 400 mg twice daily, for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo, twice daily, for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
AKST4290
Intervention Description
Oral AKST4290
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo
Primary Outcome Measure Information:
Title
Change in Motor Function During Levodopa Withdrawal.
Description
Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 Motor Examination has 33 scores based on 18 questions with several right, left, or both body distribution scores. Each Parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The minimum score on the MDS-UPDRS Part 3 is 0 and the maximum is 132.
Outcome is the mean change from Baseline in motor function during the practically defined off-medication state, defined as at least 12 hours off levodopa, at Week 12, with lower score representing better outcome.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Safety as Assessed by the Incidence, Seriousness and Severity of Adverse Events (AEs).
Description
Incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs, grouped by severity, relationship to study treatment, and AEs leading to discontinuation of study participation. Incidence was presented as number of subject with TEAEs and serious TEAEs, grouped by severity, relationship to study treatment, and AEs leading to discontinuation of study participation, throughout study duration.
Time Frame
Baseline to week 14
Title
Evaluation of Laboratory Changes.
Description
Incidence of of abnormalities or clinically significant changes from Baseline in laboratory test data (chemistry, hematology, coagulation, and urinalysis). Incidence was presented as number of subjects abnormal labs indicating serious condition occurred within the analysis population throughout study duration.
Time Frame
Baseline to week 14
Title
Evaluation of Vital Sign Changes.
Description
Incidence of abnormalities or clinically-significant changes from Baseline in Vital sign measurements (blood pressure as measured in mmHg, heart rate as measured in beats per minute, and temperature as measured in degrees Fahrenheit or Celsius). Incidence was presented as number of subjects with abnormalities or clinically-significant changes from Baseline in Vital sign measurements within the analysis group throughout study duration.
Time Frame
Baseline to week 12
Title
Evaluation of Electrocardiogram Changes.
Description
Incidence of abnormalities or clinically-significant changes from Baseline in 12-lead electrocardiogram (ECG) QT-interval. Incidence was presented as number of subject with ECG changes throughout study duration.
Time Frame
Baseline to week 12
Title
The Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts 1-4, Change From Baseline During the On-medication State.
Description
The MDS-UPDRS has 4 components (details below). The rating for each item is from 0 (normal) to 4 (severe). The score for each Part is obtained from the sum of the corresponding item scores, with higher scores indicating more severe impairment.
Part I, Non-Motor Aspects (Mentation, Behavior, and Mood) of Experiences of Daily Living (13 items), score range is 0-52.
Part II, Motor Aspects of Experiences of Daily Living (13 items), score range is 0-52.
Part III, Motor Examination (33 items), score range is 0-132. Part IV, Motor Complications (6 items), score range is 0-24. The outcome is the mean change from Baseline motor function during the on-medication state at Week 12, with lower value representing a better outcome.
Time Frame
Baseline to week 12
Title
The Montreal Cognitive Assessment (MoCA), Change From Baseline in MoCA During the On-medication State.
Description
The Montreal Cognitive Assessment (MoCA) is a neuropsychological tool that requires approximately 15 minutes to assess the following domains: attention, executive function, memory, language, visuoconstructional skills, and orientation. MoCA scores range between 0 and 30, with higher scores indicating more intact cognition.
The MoCA is administered at Baseline and Week 12 in the on-medication state. The total score will be summarized at each scheduled time point.
The outcome is mean change from baseline in MoCA during the on-medication state at Week 12, with higher value representing a better outcome.
Time Frame
Baseline to week 12
Title
The Schwab and England Activities of Daily Living (SE-ADL) Scale, Change From Baseline in SE-ADL During the On-medication State.
Description
The SE-ADL evaluates patients' perceptions of global functional capacity and dependence. Scoring is expressed in terms of percentage, in 10 steps from 100 to 0 (100% indicates completely independent, 0% indicates bedridden with impaired vegetative functions), so that the lower the score, the worse the functional status. Scores will be summarized descriptively at each scheduled time point (i.e. n, %) by treatment group. A Generalized Estimating Equations (GEE) for alternating logistic regression (ALR) with an exchangeable working correlation structure will be employed to analyze change from baseline.
Outcome is mean change from baseline in SE-ADL during the on-medication state at Week 12, with higher values represents a better outcome.
Time Frame
Baseline to week 12
Title
The Clinical Impression of Severity Index - PD (CISI-PD), Change From Baseline in CISI-PD During the On-medication State.
Description
The CISI-PD is a severity index formed by four items (motor signs, disability, motor complications, and cognitive status), rated 0 (not at all) to 6 (very severe or completely disabled). A total score is calculated by summing the item scores, total scores range from 0-24. The outcome is the mean change from baseline in CISI-PD during the on-medication state at Week 12, with lower score represents a better outcome.
Time Frame
Baseline to week 12
Title
The Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39), Change From Baseline in PDQ-39 During the On-medication State.
Description
The PDQ-39 is a patient-reported outcome of 39 questions relating to 8 key areas of health and daily activities, including both motor and non-motor symptoms. The eight dimensions include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. It is scored on a scale of 0-100 with lower scores indicating better health and high scores indicating more severe symptoms, applying to all dimensions reported in the data table.
Outcome is the mean change from baseline in PDQ-39 during the on-medication state at Week 12, with lower score represents a better outcome.
Time Frame
Baseline to week 12
Title
The Sheehan-Suicidality Tracking Scale (S-STS), Change From Baseline in S-STS During the On-medication State.
Description
The standard version of the S-STS is a 16-item scale that assesses the seriousness of suicidality phenomena on a Likert-type scale (0-4) ranging from "not at all" (0) to "extremely" (4), where higher scores indicate more risk of suicidality. It also assesses the frequency of key phenomena and the overall time spent in suicidality. Total score is a sum of all items; total score ranges from 0-64.
Outcome is the mean change from baseline in S-STS during the on-medication state at Week 12, with higher score represents a worse outcome.
Time Frame
Baseline to week 12
Title
10-meter Timed Walk, Change in Baseline 10-meter Timed Walk During the on and Off-medication State
Description
The 10-meter walk test is a commonly used tool for assessing gait speed in individuals with gait limitations. Gait speed is positively correlated with the amount of community ambulation and quality of life, and it is an important measure of mobility in individuals with PD, with higher value corresponds to better mobility.
Outcome is the mean change from baseline comfortable walking speed (gait), fast walking speed (gait), during the on and off-medication state at Week 12, with higher score represents a better outcome.
Time Frame
Baseline to week 12
Title
Hauser 3-Day Patient Diary, Change in Baseline Mean Time Spent With and Without Troublesome Dyskinesia as Measured by the Hauser 3-Day Patient Diary
Description
The Hauser Patient Diary was developed to assess functional status over a period of time in patients with motor fluctuations and dyskinesia by recording patient motor state for half-hour intervals over a 24-hour period. The outcome is mean change of Mean Time Spent with and without troublesome dyskinesia from Baseline at Week 12.
ON/OFF-time is time when medication is providing/not providing benefit with regard to mobility, slowness, and stiffness, respectively.
Troublesome dyskinesia is defined as dyskinesia that interfere with function or causes meaningful discomfort. Bad time is defined as the sum of off time and on time with troublesome dyskinesia. Lower value represents a better outcome. Good time is defined as the on time without dyskinesia plus on time with non-troublesome dyskinesia. Higher value represents a better outcome.
Time Frame
Baseline to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of clinically established or clinically probable PD according to MDS-PD criteria with at least 1 year of PD symptoms.
Modified Hoehn and Yahr ≤2.5.
Have notable motor worsening during off-medication state.
Clear-cut improvement of motor response to levodopa medications, as assessed by the investigator.
Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at least 8 weeks prior to enrollment and remain on stable dose during the 12-week treatment period.
Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use highly effective contraception prior to study entry. Male subjects must be willing to use a barrier method of contraception.
Key Exclusion Criteria:
Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body dementia.
History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant).
Conditions affecting the peripheral or central nervous system, unless related to PD, that would affect the ability to adequately perform the MDS-UPDRS and motor assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke affecting motor or gait function.
Significant alcohol or drug abuse within past 2 years.
Based on ECG reading, subjects with a risk of QT prolongation.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alkahest Medical Monitor
Organizational Affiliation
Alkahest, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Henry Ford Hospital West Bloomfield
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Movement Disorder Clinic of Oklahoma PLLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
AS Ida-Tallinna Keskhaigla / East Tallinn Central Hospital
City
Tallinn
Country
Estonia
Facility Name
Astra Kliinik / Astra Team Clinic
City
Tallinn
Country
Estonia
Facility Name
Universitätsklinikum Carl Gustav Carus an der TU Dresden
City
Dresden
Country
Germany
Facility Name
Krankenhaus Agatharied GmbH
City
Hausham
Country
Germany
Facility Name
Paracelsus-Elena-Klinik Kassel
City
Kassel
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
UKGM Marburg
City
Marburg
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Centrum Medyczne PRATIA/ Medical Center PRATIA
City
Częstochowa
Country
Poland
Facility Name
Krakowska Akademia Neurologii/ Cracow Academy of Neurology
City
Kraków
Country
Poland
Facility Name
Instytut Zdrowia Dr Boczarska-Jedynak Spolka Z Oraganiczona Odpowiedzialnoscia Spolka Komandytowa/ Institute of Health dr Boczarska-Jedynak
City
Oświęcim
Country
Poland
Facility Name
Medicome SP. ZO. O./ Medicome
City
Oświęcim
Country
Poland
Facility Name
Neurologiczny Nzoz Centrum Leczenia Sm Osrodek Badan Klinicznych
City
Plewiska
Country
Poland
Facility Name
Euro-Neuro, s.r.o., Neurologická ambulancia
City
Bratislava
Country
Slovakia
Facility Name
Nemocnica Kramáre II. Neurologická klinika LF UK a UNB /2nd Dept. Of Neurology, Comenius University Faculty of Medicine and University Hospital Bratislava
City
Bratislava
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Sv. Lukáša Galanta, a. s Neurologické oddelenie /Neurology Dpt., NsP Galanta
City
Galanta
Country
Slovakia
Facility Name
Univerzitná nemocnica Martin Neurologická klinika/University hospital Martin, Clinic of Neurology
City
Martin
Country
Slovakia
12. IPD Sharing Statement
Plan to Share IPD
No
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Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment
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