Back to resultsA Study to Investigate a New Treatment in Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IPT803
Optional pharmacogenetic assessment
Questionnaires
Optional Blood-Oxygen-level Dependent functionalMRI
Motor Assessments before taking regular PD treatment
Motor Assessments on regular PD treatment
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria
- Men or women of at least 35 years of age;
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures;
- Have given written informed consent approved by the relevant Ethics Committee (EC)/Institutional Review Board (IRB) governing the study site(s);
- Medically stable outpatients with idiopathic PD based on the MDS-PD criteria (Postuma et al 2015). The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson;
- Patients with a Hoehn and Yahr Stage < 3;
- Patients with a MMSE ≥ 26;
Patient stabilized with PD medication(s) e.g. levodopa, dopamine agonists, amantadine and/or Monoamine oxidase (MAO)-B inhibitors for at least 4 weeks prior to Visit 1 and and up to Visit 4 included or Drug naïve patients recently diagnosed with PD according to the criteria above and for whom PD medication(s) may be initiated after Visit 4;
Exclusion Criteria
- Pregnant (urine pregnancy test), breastfeeding, or willing to be pregnant during the study;
- Presence of clinically significant medical or psychiatric condition that may increase the risk associated with study participation or investigational product/device administration or participation in any other type of medical research that may interfere with the interpretation of study results in the judgment of the sponsor/investigator or in an exclusion period according to national law, would make the subject inappropriate for entry into this study;
- Has a history of psychotic symptoms requiring treatment with a neuroleptic medication within the past 12 months;
- Any current primary psychiatric condition, including not stabilized mood disorders, personality disorders or mental retardation based on diagnostic following DSM-V;
- Any known hypersensitivity to corn and/or corn-derived products;
- Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine);
- Any other relevant medical disorder/acute disease state judged by the Investigator as likely to interfere with study procedures or represent a risk for the patient;
- Any close relationship with the investigators or employees or consultants of the sponsor (i.e. belonging to immediate family or subordination relationship);
- Under legal protection, according to the national law (for French sites only);
- Are persons who have previously received IPT803, have completed or withdrawn from this study or any other study investigating IPT803.
- Change in the patient's regular PD medication(s) (dosage or dosing interval) or introduction of a new regular PD medication(s) within 4 weeks prior to Visit 1 and up to Visit 4 included;
- Patients with motor complications (wearing off; dyskinesia) that would interfere with study procedures;
- Patients with history or clinical features consistent with an atypical Parkinsonian syndrome (for example: supranuclear gaze palsy, clinically significant orthostatic hypotension);
- History of surgical or invasive intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.);
Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Exclusion Imaging (BOLD fMRI) criteria for patients following Imaging Procedure:
- Patients unable to undergo MRI scans, including suffering from claustrophobia;
- Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field according to investigator site judgment.
Sites / Locations
- University of Colorado School of Medicine
- University of Florida
- Northwestern
- Henry Ford
- Columbia
- CHU Liege - Liège University
- CHU Grenoble
- CHU Poitiers
- CHU Rennes - Hopital Pontchaillou
- CHU Purpan - Hopital Pierre Paul Riquet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Assessments ON regular PD treatment
Assessments OFF regular PD treatment
Arm Description
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Outcomes
Primary Outcome Measures
Patient's change from baseline of score as measured by Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS; Part III), after 12 weeks of IPT803 administration.
Part III of the MDS-UPDRS (or motor examination) assesses the motor abilities in PD patients at the time of the visit. This part measures 18 motor examinations such as speech, facial expression, tremor, rigidity, finger tapping, pronation-supination movements of hands, leg agility, arising from chair, gait.
The qualified rater must score 34 items from 0 to 4, where 0 indicates a normal situation and 4 indicates that PD interferes severely in carrying out the task. The total score, being the sum of all these items, can be between 0 to 136.
Secondary Outcome Measures
Patient's change from baseline of safety incidence as measured by the rate and severity of Treatment emergent adverse event (TEAEs).
Patient's change from baseline of motor and non-motor outcomes as measured by Part I, Part II and IV subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
The MDS-UPDRS is divided into 4 parts. In each part, all items are rated on a scale from 0 (normal) to 4 (severe impairment).
Part I assesses 15 items of non-motor aspects of experiences of daily living. Part IA is assessed by a qualified rater, Part IB is completed by the patient. The total score, being the sum of all these items, can be between 0 to 60.
Part II comprises 13 items evaluating the impact of PD on patients' activities of daily living (ADL) over the week prior to the visit such as speech, salivation, swallowing, eating, handwriting, dressing, turning in bed, walking. It will be completed by the patient. The total score, being the sum of all these items, can be between 0 to 52.
Part IV assesses motor complications of therapy, such as dyskinesias, motor fluctuations. This part (6 items) is completed by a qualified rater. The total score, being the sum of all these items, can be between 0 to 24.
The patient's change from baseline in disease severity as measured by the Parkinson's Disease Questionnaire (PDQ-39).
Patient's change from baseline of fatigue as measured by the Fatigue Severity Scale (FSS).
The FSS is a self-administered questionnaire with 9 items assessing the severity of fatigue during the past 2 weeks. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, where the addition of all numbers circled by patient get the final score.
Patient's change from baseline of sleep quality as measured by the Epworth Sleep Scale (ESS).
The ESS assesses the overall level of daytime sleepiness. Eight items describe normative daily situations known to vary in their soporific qualities. Patients rate the likelihood of dozing off or falling asleep. The test is rated on a 4-point scale (0=would never doze off to 3=high chance of dozing off).
Investigator change from baseline in disease severity as measured by the Investigator Assessment of Changes (IGAC).
IGAC is a subjective evaluation by the Investigator using a 0 to 10 Numeric Rating Scale (NRS) to answer the following question: "If you take into consideration all the various ways that motor control influences the patient and his/her life, how do you then evaluate the patient's motor condition today?", with 0 meaning "very bad" and 10 "very good".
Patient's change from baseline in disease severity as measured by the Patient Assessment of Changes (PGAC).
PGAC is a subjective evaluation by the patient using a 0 to 10 Numeric Rating Scale (NRS) to answer the following question: "If you take into consideration all the various ways that motor control influences you and your life, how do you then evaluate your motor condition over the last week?", with 0 meaning "very bad" and 10 meaning "very good".
Patient's change from baseline above or equal to the minimal clinically important difference (MCID) of the motor score as measured by Part II and III subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
The Minimal Clinically Important Difference (MCID) is the smallest change in an outcome measure that is meaningful for patients.
In the literature, the MCIDs of MDS-UPDRS Part II and Part III are respectively defined as a motor score reduction of 2 and 6 points. The motor scores are the sum of all items (ranging from 0-4) of each MDS-UPDRS subscale.
Following endpoints will be measured:
A reduction above or equal to 2 points of MDS-UPDRS Part II motor score (minimum score= 0, maximal score= 52)
A reduction above or equal to 6 points of MDS-UPDRS Part III motor score (minimum score= 0, maximal score= 136)
These endpoints will be interpreted as binary values: 0 (below) and 1 (above or equal).
Patient's change from baseline above or equal to 30 % or above or equal to 50 % of the motor score as measured by Part II and III subscales of MDS-UPDRS.
The motor scores are the sum of all items (ranging from 0-4) of each MDS-UPDRS subscale.
Following endpoints will be measured:
A reduction above or equal to 30% of MDS-UPDRS Part II motor score
A reduction above or equal to 30% of MDS-UPDRS Part III motor score
A reduction above or equal to 50% of MDS-UPDRS Part II motor score
A reduction above or equal to 50% of MDS-UPDRS Part III motor score
These endpoints will be interpreted as binary values: 0 (below) and 1 (above or equal).
Cronbach α assessment of MPsQ
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03407378
Brief Title
A Study to Investigate a New Treatment in Patients With Parkinson's Disease
Official Title
A Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tools4Patient
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessments ON regular PD treatment
Arm Type
Experimental
Arm Description
IPT803 Questionnaires Motor assessments on regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Arm Title
Assessments OFF regular PD treatment
Arm Type
Experimental
Arm Description
IPT803 Questionnaires Motor assessments before taking regular PD treatment Optional pharmacogenetic assessments Optional Blood-Oxygen-level Dependent Functional-MRI
Intervention Type
Drug
Intervention Name(s)
IPT803
Intervention Description
Administration of IPT803 three times a day for 12 weeks as add-on therapy to patient regular PD medication(s) or as a new therapy for drug naïve patients.
Intervention Type
Genetic
Intervention Name(s)
Optional pharmacogenetic assessment
Intervention Description
Blood sample of 3 milliliters for genotyping assessment (according to patient consent).
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)
Intervention Type
Other
Intervention Name(s)
Optional Blood-Oxygen-level Dependent functionalMRI
Intervention Description
BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)
Intervention Type
Other
Intervention Name(s)
Motor Assessments before taking regular PD treatment
Intervention Description
Regular PD treatment stopped 12 or 24 hours prior to Visits 2, 3 and 4 depending on the drug form (extended vs standard release). Motor assessments using UPDRS Part III are performed when patients are OFF regular PD treatment. Regular PD treatment is taken on site during the visit after the motor assessments are performed.
Intervention Type
Other
Intervention Name(s)
Motor Assessments on regular PD treatment
Intervention Description
Regular PD treatment is not modified before the visits. The motor assessments using UPDRS Part III are performed while the patient is on regular PD treatment.
Primary Outcome Measure Information:
Title
Patient's change from baseline of score as measured by Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS; Part III), after 12 weeks of IPT803 administration.
Description
Part III of the MDS-UPDRS (or motor examination) assesses the motor abilities in PD patients at the time of the visit. This part measures 18 motor examinations such as speech, facial expression, tremor, rigidity, finger tapping, pronation-supination movements of hands, leg agility, arising from chair, gait.
The qualified rater must score 34 items from 0 to 4, where 0 indicates a normal situation and 4 indicates that PD interferes severely in carrying out the task. The total score, being the sum of all these items, can be between 0 to 136.
Time Frame
Time zero equals baseline equals (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Secondary Outcome Measure Information:
Title
Patient's change from baseline of safety incidence as measured by the rate and severity of Treatment emergent adverse event (TEAEs).
Time Frame
Time zero equals baseline Visit 2 IPT803 first dose (Day 1) up to Visit 4 (Day 85)
Title
Patient's change from baseline of motor and non-motor outcomes as measured by Part I, Part II and IV subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Description
The MDS-UPDRS is divided into 4 parts. In each part, all items are rated on a scale from 0 (normal) to 4 (severe impairment).
Part I assesses 15 items of non-motor aspects of experiences of daily living. Part IA is assessed by a qualified rater, Part IB is completed by the patient. The total score, being the sum of all these items, can be between 0 to 60.
Part II comprises 13 items evaluating the impact of PD on patients' activities of daily living (ADL) over the week prior to the visit such as speech, salivation, swallowing, eating, handwriting, dressing, turning in bed, walking. It will be completed by the patient. The total score, being the sum of all these items, can be between 0 to 52.
Part IV assesses motor complications of therapy, such as dyskinesias, motor fluctuations. This part (6 items) is completed by a qualified rater. The total score, being the sum of all these items, can be between 0 to 24.
Time Frame
From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
Title
The patient's change from baseline in disease severity as measured by the Parkinson's Disease Questionnaire (PDQ-39).
Time Frame
From Visit 2 (Day 1) up to Visit 4 (Day 85)
Title
Patient's change from baseline of fatigue as measured by the Fatigue Severity Scale (FSS).
Description
The FSS is a self-administered questionnaire with 9 items assessing the severity of fatigue during the past 2 weeks. Grading of each item ranges from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement, where the addition of all numbers circled by patient get the final score.
Time Frame
From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
Title
Patient's change from baseline of sleep quality as measured by the Epworth Sleep Scale (ESS).
Description
The ESS assesses the overall level of daytime sleepiness. Eight items describe normative daily situations known to vary in their soporific qualities. Patients rate the likelihood of dozing off or falling asleep. The test is rated on a 4-point scale (0=would never doze off to 3=high chance of dozing off).
Time Frame
From Visit 1 (Day -14 to Day -7) up to Visit 4 (Day 85)
Title
Investigator change from baseline in disease severity as measured by the Investigator Assessment of Changes (IGAC).
Description
IGAC is a subjective evaluation by the Investigator using a 0 to 10 Numeric Rating Scale (NRS) to answer the following question: "If you take into consideration all the various ways that motor control influences the patient and his/her life, how do you then evaluate the patient's motor condition today?", with 0 meaning "very bad" and 10 "very good".
Time Frame
From Visit 2 (Day 1) up to Visit 4 (Day 85)
Title
Patient's change from baseline in disease severity as measured by the Patient Assessment of Changes (PGAC).
Description
PGAC is a subjective evaluation by the patient using a 0 to 10 Numeric Rating Scale (NRS) to answer the following question: "If you take into consideration all the various ways that motor control influences you and your life, how do you then evaluate your motor condition over the last week?", with 0 meaning "very bad" and 10 meaning "very good".
Time Frame
From Visit 2 (Day 1) up to Visit 4 (Day 85)
Title
Patient's change from baseline above or equal to the minimal clinically important difference (MCID) of the motor score as measured by Part II and III subscales of Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
Description
The Minimal Clinically Important Difference (MCID) is the smallest change in an outcome measure that is meaningful for patients.
In the literature, the MCIDs of MDS-UPDRS Part II and Part III are respectively defined as a motor score reduction of 2 and 6 points. The motor scores are the sum of all items (ranging from 0-4) of each MDS-UPDRS subscale.
Following endpoints will be measured:
A reduction above or equal to 2 points of MDS-UPDRS Part II motor score (minimum score= 0, maximal score= 52)
A reduction above or equal to 6 points of MDS-UPDRS Part III motor score (minimum score= 0, maximal score= 136)
These endpoints will be interpreted as binary values: 0 (below) and 1 (above or equal).
Time Frame
Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Title
Patient's change from baseline above or equal to 30 % or above or equal to 50 % of the motor score as measured by Part II and III subscales of MDS-UPDRS.
Description
The motor scores are the sum of all items (ranging from 0-4) of each MDS-UPDRS subscale.
Following endpoints will be measured:
A reduction above or equal to 30% of MDS-UPDRS Part II motor score
A reduction above or equal to 30% of MDS-UPDRS Part III motor score
A reduction above or equal to 50% of MDS-UPDRS Part II motor score
A reduction above or equal to 50% of MDS-UPDRS Part III motor score
These endpoints will be interpreted as binary values: 0 (below) and 1 (above or equal).
Time Frame
Time zero equals baseline (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Title
Cronbach α assessment of MPsQ
Time Frame
at Visit 1 (Day -14 to Day -7), Visit 2 (Day 1) Visit 4 (Day 85)
Other Pre-specified Outcome Measures:
Title
Patient's change from baseline of motor score, as measured by Inertial Measurement Unit (IMU) on Finger taping (FT) and Pronation-supination movement of the hands (PSH) during the 12-week treatment.
Description
For all patients, objective quantitative movement will be collected with movement sensors (accelerometers and gyroscopes) during items 3.4 (FT) and 3.6 (PSH) of MDS-UPDRS Part III at Visits 2, 3 and 4.
Collected data will be converted to continuous values on the same scale as MDS-UPDRS, from 0 to 4. The endpoint is defined as the patient's change from baseline of these continuous scales.
Time Frame
Time zero equals baseline equals (Visit 2 - Day 1 prior to IPT803 first dose) up to Visit 4 (Day 85)
Title
Patient's change from baseline of the regional brain activity as measured by BOLD fMRI measured by motor tasks performed during fMRI before and after single dose of IPT803.
Time Frame
On Day 1: prior to IPT 803 first dose and 60 minutes after IPT803 first dose
Title
Patient's change of motor score, as measured by Part III subscale of MDS-UPDRS directly after IPT803 single dose.
Description
The qualified rater must score 34 items from 0 to 4, where 0 indicates a normal situation and 4 indicates that PD interferes severely in carrying out the task. The total score, being the sum of all these items, can be between 0 to 136.
Time Frame
On Day 1: prior to IPT 803 first dose and 30 minutes after IPT803 first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Men or women of at least 35 years of age;
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures;
Have given written informed consent approved by the relevant Ethics Committee (EC)/Institutional Review Board (IRB) governing the study site(s);
Medically stable outpatients with idiopathic PD based on the MDS-PD criteria (Postuma et al 2015). The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson;
Patients with a Hoehn and Yahr Stage < 3;
Patients with a MMSE ≥ 26;
Patient stabilized with PD medication(s) e.g. levodopa, dopamine agonists, amantadine and/or Monoamine oxidase (MAO)-B inhibitors for at least 4 weeks prior to Visit 1 and and up to Visit 4 included or Drug naïve patients recently diagnosed with PD according to the criteria above and for whom PD medication(s) may be initiated after Visit 4;
Exclusion Criteria
Pregnant (urine pregnancy test), breastfeeding, or willing to be pregnant during the study;
Presence of clinically significant medical or psychiatric condition that may increase the risk associated with study participation or investigational product/device administration or participation in any other type of medical research that may interfere with the interpretation of study results in the judgment of the sponsor/investigator or in an exclusion period according to national law, would make the subject inappropriate for entry into this study;
Has a history of psychotic symptoms requiring treatment with a neuroleptic medication within the past 12 months;
Any current primary psychiatric condition, including not stabilized mood disorders, personality disorders or mental retardation based on diagnostic following DSM-V;
Any known hypersensitivity to corn and/or corn-derived products;
Alcohol dependence or regular use of known drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine);
Any other relevant medical disorder/acute disease state judged by the Investigator as likely to interfere with study procedures or represent a risk for the patient;
Any close relationship with the investigators or employees or consultants of the sponsor (i.e. belonging to immediate family or subordination relationship);
Under legal protection, according to the national law (for French sites only);
Are persons who have previously received IPT803, have completed or withdrawn from this study or any other study investigating IPT803.
Change in the patient's regular PD medication(s) (dosage or dosing interval) or introduction of a new regular PD medication(s) within 4 weeks prior to Visit 1 and up to Visit 4 included;
Patients with motor complications (wearing off; dyskinesia) that would interfere with study procedures;
Patients with history or clinical features consistent with an atypical Parkinsonian syndrome (for example: supranuclear gaze palsy, clinically significant orthostatic hypotension);
History of surgical or invasive intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.);
Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Exclusion Imaging (BOLD fMRI) criteria for patients following Imaging Procedure:
Patients unable to undergo MRI scans, including suffering from claustrophobia;
Have implanted or embedded metal objects or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field according to investigator site judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pereira Alvaro
Organizational Affiliation
Tools4Patient
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Northwestern
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Henry Ford
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
CHU Liege - Liège University
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Purpan - Hopital Pierre Paul Riquet
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate a New Treatment in Patients With Parkinson's Disease
We'll reach out to this number within 24 hrs