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Open-label Trial in Parkinson's Disease (PD) (TEMPO-4)

Primary Purpose

Parkinson Disease

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tavapadon
Sponsored by
Cerevel Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Rollover participants are eligible for the study if they met the following inclusion criteria:

  • Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
  • Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
  • Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
  • Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
  • Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial.

Key Exclusion criteria:

Rollover participants are excluded from the trial if any of the following met:

  • Participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial
  • Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
  • Participants who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Sites / Locations

  • Birmingham, Alabama
  • Pheonix, Arizona
  • Little Rock, Arkansas
  • Fountain Valley, California
  • Fresno, California
  • Los Angeles, California
  • Pasadena, California
  • Englewood, Colorado
  • Florida, United States
  • Boca Raton, Florida
  • Coral Springs, Florida
  • Maitland, Florida
  • Ocala, Florida
  • Port Charlotte, Florida
  • Tampa, Florida
  • Winter Park, Florida
  • Augusta, Georgia
  • Chicago, Illinois
  • Winfield, Illinois
  • Kansas City
  • Lexington, Kentucky
  • Scarborough, Maine
  • Boston, Massachusettes
  • East Lansing, Michigan
  • West Bloomfield, Michigan
  • Las Vegas, Nevada
  • Albany, New York
  • Syracuse, New York
  • Asheville, North Carolina
  • Durham, North Carolina
  • Cincinnati, Ohio
  • Cleveland, Ohio
  • Columbus, Ohio
  • Toledo, Ohio
  • Philadelphia, Pennsylvania
  • Memphis, Tennessee
  • Georgetown, Texas
  • Houston, Texas
  • Lubbock, Texas
  • Round Rock, Texas
  • Burlington, Vermont
  • Richmond, Virginia
  • Richmond, Virginia
  • Virginia Beach, Virginia
  • Kirkland, Washington
  • Erina, New South Wales
  • Sydney, New South Wales
  • Woolloongabba, Queensland
  • Clayton, Victoria
  • Parkville, Victoria
  • Medical center VITA1, Pleven
  • Pleven, Bulgaria
  • Pleven
  • Multiprofile Hospital, Sofia
  • Sofia
  • Sofia
  • Sofia
  • Ottawa, Ontario
  • Toronto, Ontario
  • Chocen
  • Prague, Czech Republic
  • Prague,
  • Prague,
  • Rychnov nad Kněžnou
  • Creteil,
  • Boulevard Pinel, Bron
  • Grenoble cedex
  • Nîmes cedex 09
  • Strasbourg
  • Toulouse Cedex 9
  • Muenster
  • Bad Homburg
  • Berlin
  • Bochum
  • Gera
  • Haag in Oberbayern
  • Muenchen
  • München
  • Stadtroda
  • Budapest
  • Pecs
  • Tatabanya
  • Haifa
  • Petah Tiqva
  • Ramat Gan
  • Shoham
  • Tel Aviv
  • Ancona
  • Cassino
  • Milano, Italy
  • Milano
  • Padova
  • Pisa
  • Rome
  • Rome
  • Rome
  • Torino
  • Cracow
  • Siemianowice Slaskie
  • Centrum Medyczne NEUROMED
  • Katowice
  • Katowice
  • Krakow
  • Kraków
  • Centrum Medyczne Hope Clinic Sebastian Szklener
  • Warsaw
  • Singua
  • Belgrade,
  • Belgrade
  • Belgrade, Kragujevac
  • Elche
  • Barcelona
  • Barcelona
  • Sant Cugat del Vallés Barcelona
  • Madrid
  • Móstoles, Madrid
  • Pamplona
  • San Sebastian
  • Terrassa
  • Valencia
  • Zaporiizhzhya
  • Dnipro
  • Lviv
  • Vinnitsa
  • Medical Center, Zaporizhzhya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tavapadon

Arm Description

Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, Vital Signs, Physical and Neurological evaluations and ECGs will be reported as TEAEs.
Number of Participants Who Discontinued Study Treatment
A participant may discontinue the study treatment due to any of the following reasons: adverse event, death, worsening of PD symptoms to such an extent that, in the judgement of the investigator, the participant requires additional anti-PD medications, treatment with a prohibited concomitant medication, noncompliance with the trial schedule or procedures, withdrawal of consent, pregnancy, investigator discretion.
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.
Epworth Sleepiness Scale (ESS)
ESS is a scale that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated as 0 = would never nod off, 1 = slight chance of nodding off, 2 = moderate chance of nodding off, or 3 = high chance of nodding off. A score greater than or equal to (> =) 10 indicates that the participant may need to get more sleep, improve sleep practices, or seek medical attention to determine why he or she is sleepy.
Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Study Medication Withdrawal Questionnaire (SMWQ)
SMWQ is a questionnaire to assess withdrawal symptoms subsequent to completion of dosing with Investigational medicinal product (IMP). The SMWQ is a modification of the Amphetamine Withdrawal Questionnaire, in which the first question "Have you been craving amphetamine or methamphetamine?" is replaced with "Have you been craving the trial medication?" This change is intended to prevent bias by implying that the trial medication might be an amphetamine or amphetamine-like stimulant when presented with the survey. Participants will complete the SMWQ onsite when they are at a designated trial visit; on days when the participant is not onsite, they will complete the SMWQ remotely.
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III
The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III combined score will be assessed.
Change From Baseline in the Hauser diary
The Hauser diary (Hauser et al, 2000) assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep.
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index
EQ-5D-5L is a survey instrument used for participant-reported outcome that measures health in 5 dimensions. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels of perceived problems (1 = no problem, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems). Participant selects an answer for each of 5 dimensions considering the response that best matches his/her health "today". The digits for the 5 dimensions are combined into a 5-digit number that describes the participant's health state.
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)
EQ-5D-5L VAS is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. The EQ-5D-5L VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).

Secondary Outcome Measures

Full Information

First Posted
February 12, 2021
Last Updated
September 6, 2023
Sponsor
Cerevel Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04760769
Brief Title
Open-label Trial in Parkinson's Disease (PD)
Acronym
TEMPO-4
Official Title
58-Week Open-label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinsonian Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tavapadon
Arm Type
Experimental
Arm Description
Participants will receive a Tavapadon tablet at a dose of 5 milligrams (mg) to 15 mg once daily (QD) orally during 58-week treatment period.
Intervention Type
Drug
Intervention Name(s)
Tavapadon
Other Intervention Name(s)
PF-06649751, CVL-751
Intervention Description
Participants will receive Tavapadon at a dose of (5 to 15) mg QD, orally during a 58-week treatment period.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, Vital Signs, Physical and Neurological evaluations and ECGs will be reported as TEAEs.
Time Frame
62 Weeks
Title
Number of Participants Who Discontinued Study Treatment
Description
A participant may discontinue the study treatment due to any of the following reasons: adverse event, death, worsening of PD symptoms to such an extent that, in the judgement of the investigator, the participant requires additional anti-PD medications, treatment with a prohibited concomitant medication, noncompliance with the trial schedule or procedures, withdrawal of consent, pregnancy, investigator discretion.
Time Frame
62 Weeks
Title
Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
Description
QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.
Time Frame
58 Weeks
Title
Epworth Sleepiness Scale (ESS)
Description
ESS is a scale that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated as 0 = would never nod off, 1 = slight chance of nodding off, 2 = moderate chance of nodding off, or 3 = high chance of nodding off. A score greater than or equal to (> =) 10 indicates that the participant may need to get more sleep, improve sleep practices, or seek medical attention to determine why he or she is sleepy.
Time Frame
58 Weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Time Frame
60 Weeks
Title
Study Medication Withdrawal Questionnaire (SMWQ)
Description
SMWQ is a questionnaire to assess withdrawal symptoms subsequent to completion of dosing with Investigational medicinal product (IMP). The SMWQ is a modification of the Amphetamine Withdrawal Questionnaire, in which the first question "Have you been craving amphetamine or methamphetamine?" is replaced with "Have you been craving the trial medication?" This change is intended to prevent bias by implying that the trial medication might be an amphetamine or amphetamine-like stimulant when presented with the survey. Participants will complete the SMWQ onsite when they are at a designated trial visit; on days when the participant is not onsite, they will complete the SMWQ remotely.
Time Frame
60 Weeks
Title
Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III
Description
The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III combined score will be assessed.
Time Frame
60 Weeks
Title
Change From Baseline in the Hauser diary
Description
The Hauser diary (Hauser et al, 2000) assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep.
Time Frame
58 Weeks
Title
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index
Description
EQ-5D-5L is a survey instrument used for participant-reported outcome that measures health in 5 dimensions. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels of perceived problems (1 = no problem, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems). Participant selects an answer for each of 5 dimensions considering the response that best matches his/her health "today". The digits for the 5 dimensions are combined into a 5-digit number that describes the participant's health state.
Time Frame
Baseline (Day 1), Weeks 32 and 58
Title
Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS)
Description
EQ-5D-5L VAS is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. The EQ-5D-5L VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time Frame
Baseline (Day 1), Weeks 32 and 58

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Rollover participants are eligible for the study if they met the following inclusion criteria: Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial. Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment. Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial. Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial. Key Exclusion criteria: Rollover participants are excluded from the trial if any of the following met: Participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide. Participants who had previously been enrolled in this open-label trial and had subsequently withdrawn.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cari Combs, MD
Organizational Affiliation
Cerevel Therapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham, Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pheonix, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Little Rock, Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Fountain Valley, California
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Fresno, California
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Los Angeles, California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pasadena, California
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Englewood, Colorado
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Florida, United States
City
Adventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Boca Raton, Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Coral Springs, Florida
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Maitland, Florida
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Ocala, Florida
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Port Charlotte, Florida
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Facility Name
Tampa, Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Winter Park, Florida
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Augusta, Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Chicago, Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Winfield, Illinois
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Kansas City
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Lexington, Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Scarborough, Maine
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Boston, Massachusettes
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
East Lansing, Michigan
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
West Bloomfield, Michigan
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Las Vegas, Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Albany, New York
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Syracuse, New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Asheville, North Carolina
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Durham, North Carolina
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Cincinnati, Ohio
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Cleveland, Ohio
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Columbus, Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Toledo, Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Philadelphia, Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Memphis, Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38157
Country
United States
Facility Name
Georgetown, Texas
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Houston, Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Lubbock, Texas
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Round Rock, Texas
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Burlington, Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Richmond, Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Richmond, Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Virginia Beach, Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Kirkland, Washington
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Erina, New South Wales
City
Erina
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Sydney, New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Woolloongabba, Queensland
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Clayton, Victoria
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Parkville, Victoria
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Medical center VITA1, Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Pleven, Bulgaria
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital, Sofia
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Sofia
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Facility Name
Sofia
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Sofia
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Ottawa, Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y4E9
Country
Canada
Facility Name
Toronto, Ontario
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Chocen
City
Choceň
State/Province
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Prague, Czech Republic
City
Prague
State/Province
Czech Republic
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Prague,
City
Prague
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Prague,
City
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Rychnov nad Kněžnou
City
Rychnov Nad Kněžnou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
Creteil,
City
Créteil
State/Province
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Boulevard Pinel, Bron
City
Bron
ZIP/Postal Code
69500
Country
France
Facility Name
Grenoble cedex
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Nîmes cedex 09
City
Nîmes cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Toulouse Cedex 9
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Muenster
City
Münster
State/Province
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Bad Homburg
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Berlin
City
Berlin
ZIP/Postal Code
12163
Country
Germany
Facility Name
Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Gera
City
Gera
ZIP/Postal Code
D-07551
Country
Germany
Facility Name
Haag in Oberbayern
City
Haag In Oberbayern
ZIP/Postal Code
83527
Country
Germany
Facility Name
Muenchen
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Stadtroda
City
Stadtroda
ZIP/Postal Code
07646
Country
Germany
Facility Name
Budapest
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Pecs
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Tatabanya
City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Haifa
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Petah Tiqva
City
Petah Tiqva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Ramat Gan
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Shoham
City
Shoham
ZIP/Postal Code
6083531
Country
Israel
Facility Name
Tel Aviv
City
Tel Aviv
ZIP/Postal Code
6100000
Country
Israel
Facility Name
Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Cassino
City
Cassino
ZIP/Postal Code
03043
Country
Italy
Facility Name
Milano, Italy
City
Milano
ZIP/Postal Code
20126
Country
Italy
Facility Name
Milano
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Rome
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Rome
City
Rome
ZIP/Postal Code
00163
Country
Italy
Facility Name
Rome
City
Rome
ZIP/Postal Code
00179
Country
Italy
Facility Name
Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Cracow
City
Cracovia
State/Province
Cracow
ZIP/Postal Code
31-505
Country
Poland
Facility Name
Siemianowice Slaskie
City
Siemianowice Śląskie
State/Province
Siemianowice Slaskie
ZIP/Postal Code
41-100
Country
Poland
Facility Name
Centrum Medyczne NEUROMED
City
Bydgoszcz
ZIP/Postal Code
85-163
Country
Poland
Facility Name
Katowice
City
Katowice
ZIP/Postal Code
40-097
Country
Poland
Facility Name
Katowice
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Facility Name
Krakow
City
Krakow
ZIP/Postal Code
30-721
Country
Poland
Facility Name
Kraków
City
Kraków
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Medyczne Hope Clinic Sebastian Szklener
City
Lublin
ZIP/Postal Code
20-701
Country
Poland
Facility Name
Warsaw
City
Warsaw
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Singua
City
Warsaw
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Belgrade,
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Belgrade, Kragujevac
City
Belgrade
ZIP/Postal Code
11060
Country
Serbia
Facility Name
Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Barcelona
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Sant Cugat del Vallés Barcelona
City
Barcelona
ZIP/Postal Code
08190
Country
Spain
Facility Name
Madrid
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Móstoles, Madrid
City
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Pamplona
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
San Sebastian
City
San Sebastian
ZIP/Postal Code
20009
Country
Spain
Facility Name
Terrassa
City
Terrassa
ZIP/Postal Code
08222
Country
Spain
Facility Name
Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Zaporiizhzhya
City
Zaporizhzhya
State/Province
Zaporiizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Dnipro
City
Dnipro
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Lviv
City
Lviv
Country
Ukraine
Facility Name
Vinnitsa
City
Vinnitsa
ZIP/Postal Code
21050
Country
Ukraine
Facility Name
Medical Center, Zaporizhzhya
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Open-label Trial in Parkinson's Disease (PD)

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