A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Phase 3

Completed

Conditions: Parkinson's Disease (PD)

Interventions: Drug: ABBV-951

Registration Number: NCT03781167

Lead Sponsor: AbbVie

Brief Summary: The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 244

Inclusion Criteria

Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria

Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABBV-951 High Dose Subgroup	ABBV-951	After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
ABBV-951 Low Dose Subgroup	ABBV-951	After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events of Special Interest	From first dose of study drug until 30 days following last dose of study drug (up to 480 days)	Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.
Hemoglobin (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Number of Participants With Adverse Events	From first dose of study drug until 30 days following last dose of study drug (up to 480 days)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Hematocrit (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale	Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52	Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria \> 2 or \> C was recorded as an adverse event (AE).
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Albumin (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Monocytes (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Creatinine (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Neutrophils (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Sodium (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Lymphocytes (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Absolute Platelet Count (Hematology): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Potassium (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Calcium (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Glucose (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Magnesium (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study	Baseline, Weeks 6, 26, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
pH (Urinalysis): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Specific Gravity (Urinalysis): Change From Baseline to End of Study	Baseline, Weeks 6, 26, 39, and 52	Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study	Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)	Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study	Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)	Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study	Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)	Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study	Baseline, Day 1 (postdose), Weeks 6 and 52	12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Secondary Outcome Measures

Name	Time	Method
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study	Baseline, Weeks 1, 6, 13, 26, 39, and 52	Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study	Baseline, Weeks 6, 13, 26, 39, and 52	The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.
Average Daily Normalized "Off" Time: Change From Baseline to End of Study	Baseline, Weeks 1, 6, 13, 26, 39, and 52	Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study	Baseline, Weeks 6, 13, 26, 39, and 52	The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 \[never\] to 4 \[very often\] with the exception of Question 1 score ranging from 0 \[very often\] to 4 \[never\]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study	Baseline, Weeks 1, 6, 13, 26, 39, and 52	Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study	Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52	The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study	Baseline, Weeks 6, 13, 26, 39, and 52	The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.

Trial Locations

Locations (65): Hospital Santa Creu i Sant Pau /ID# 208240
🇪🇸
Barcelona, Spain
Northwestern University Feinberg School of Medicine /ID# 208812
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital /ID# 207993
🇺🇸
Boston, Massachusetts, United States
Kliniken Beelitz GmbH /ID# 208600
🇩🇪
Beelitz-Heilstaetten, Germany
University of Colorado Hospital /ID# 207968
🇺🇸
Aurora, Colorado, United States
Health Partners /ID# 207950
🇺🇸
Saint Paul, Minnesota, United States
Perron Institute /ID# 207627
🇦🇺
Nedlands, Western Australia, Australia
University of Alabama at Birmingham - Main /ID# 207996
🇺🇸
Birmingham, Alabama, United States
Indiana Clinical Research Cent /ID# 207952
🇺🇸
Indianapolis, Indiana, United States
Univ Texas HSC San Antonio /ID# 208958
🇺🇸
San Antonio, Texas, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
🇺🇸
Boca Raton, Florida, United States
Baylor College of Medicine /ID# 207620
🇺🇸
Houston, Texas, United States
Prisma Health Cancer Institute-Faris Road /ID# 207650
🇺🇸
Greenville, South Carolina, United States
Royal Adelaide Hospital /ID# 207634
🇦🇺
Adelaide, South Australia, Australia
AZ Sint-Jan Brugge /ID# 208178
🇧🇪
Brugge, Belgium
Azienda Ospedaliera di Padova /ID# 208077
🇮🇹
Padova, Italy
National Hospital Organization Utano National Hospital /ID# 210912
🇯🇵
Kyoto-shi, Kyoto, Japan
Alfred Health /ID# 207632
🇦🇺
Melbourne, Victoria, Australia
Groupe Sante CHC - Clinique du MontLegia /ID# 208177
🇧🇪
Liege, Belgium
Aarhus University Hospital /ID# 207668
🇩🇰
Aarhus N, Midtjylland, Denmark
IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975
🇮🇹
Messina, Italy
Bispebjerg and Frederiksberg Hospital /ID# 207669
🇩🇰
Copenhagen NV, Hovedstaden, Denmark
InnKlinikum Haag /ID# 208601
🇩🇪
Haag, Germany
Osaka University Hospital /ID# 210913
🇯🇵
Suita-shi, Osaka, Japan
St. Antonius Ziekenhuis /ID# 208529
🇳🇱
Nieuwegein, Netherlands
Hospital Universitario A Coruna - CHUAC /ID# 212147
🇪🇸
A Coruna, Spain
Skane University Hospital Lund /ID# 207811
🇸🇪
Lund, Skane Lan, Sweden
King's College Hospital NHS Foundation Trust /ID# 208413
🇬🇧
London, United Kingdom
University of Kentucky Chandler Medical Center /ID# 207603
🇺🇸
Lexington, Kentucky, United States
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
🇺🇸
Fountain Valley, California, United States
Univ Kansas Med Ctr /ID# 208963
🇺🇸
Kansas City, Kansas, United States
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784
🇺🇸
Raleigh, North Carolina, United States
Dartmouth-Hitchcock Medical Center /ID# 207972
🇺🇸
Lebanon, New Hampshire, United States
Washington University-School of Medicine /ID# 207525
🇺🇸
Saint Louis, Missouri, United States
University of Missouri /ID# 209043
🇺🇸
Columbia, Missouri, United States
Neurology Consultants of Dallas - LBJ Fwy /ID# 207619
🇺🇸
Dallas, Texas, United States
Central Texas Neurology Consul /ID# 216918
🇺🇸
Round Rock, Texas, United States
Booth Gardner Parkinson's Care Center /ID# 208026
🇺🇸
Kirkland, Washington, United States
Concord Repatriation General Hospital /ID# 207628
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Concord, New South Wales, Australia
Inland Northwest Research /ID# 208122
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Spokane, Washington, United States
Medical College of Wisconsin /ID# 207999
🇺🇸
Milwaukee, Wisconsin, United States
Westmead Hospital /ID# 207633
🇦🇺
Westmead, New South Wales, Australia
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955
🇮🇹
Milan, Italy
Universitaetsklinikum Ulm /ID# 208602
🇩🇪
Ulm, Baden-Wuerttemberg, Germany
Odense University Hospital /ID# 207871
🇩🇰
Odense C, Syddanmark, Denmark
National Hospital Organization Asahikawa Medical Center /ID# 210914
🇯🇵
Asahikawa-shi, Hokkaido, Japan
National Center of Neurology and Psychiatry /ID# 210911
🇯🇵
Kodaira-shi, Tokyo, Japan
City Clinical Hospital #40 /ID# 216301
🇷🇺
Sestroretsk, Sankt-Peterburg, Russian Federation
Juntendo University Hospital /ID# 210915
🇯🇵
Bunkyo-ku, Tokyo, Japan
Erasmus Medisch Centrum /ID# 208168
🇳🇱
Rotterdam, Zuid-Holland, Netherlands
Hospital Universitario de Bellvitge /ID# 209539
🇪🇸
L'Hospitalet de Llobregat, Barcelona, Spain
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303
🇷🇺
St. Petersburg, Sankt-Peterburg, Russian Federation
Centrum for neurologi /ID# 207716
🇸🇪
Stockholm, Stockholms Lan, Sweden
Hospital Universitario Virgen de las Nieves /ID# 208242
🇪🇸
Granada, Spain
Hospital Universitario Ramon y Cajal /ID# 208241
🇪🇸
Madrid, Spain
NHS Tayside /ID# 209242
🇬🇧
Dundee, Scotland, United Kingdom
Hospital Universitario Virgen del Rocio /ID# 208239
🇪🇸
Sevilla, Spain
Sahlgrenska University Hospital /ID# 207718
🇸🇪
Gothenburg, Vastra Gotalands Lan, Sweden
University Hospital Plymouth NHS Trust /ID# 208447
🇬🇧
Plymouth, United Kingdom
Universitair Ziekenhuis Leuven /ID# 209058
🇧🇪
Leuven, Vlaams-Brabant, Belgium
Centre de Recherche St-Louis /ID# 207344
🇨🇦
Quebec City, Quebec, Canada
Legacy Medical Group - Neurology /ID# 208031
🇺🇸
Portland, Oregon, United States
University of Calgary - Movement Disorders Clinic /ID# 207342
🇨🇦
Calgary, Alberta, Canada
Hospital General Universitario de Elche /ID# 209777
🇪🇸
Elche, Alicante, Spain
Banner Sun Health Res Inst /ID# 208811
🇺🇸
Sun City, Arizona, United States

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