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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Solution for continuous subcutaneous infusion (CSCI)
Number of Participants With Adverse Events
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.
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Number of Participants With Adverse Events of Special Interest
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.
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
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
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).
Time frame: Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
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University of Alabama at Birmingham - Main /ID# 207996
Birmingham, Alabama, United States
Banner Sun Health Res Inst /ID# 208811
Sun City, Arizona, United States
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
Fountain Valley, California, United States
University of Colorado Hospital /ID# 207968
Aurora, Colorado, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
Boca Raton, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 208812
Chicago, Illinois, United States
Indiana Clinical Research Cent /ID# 207952
Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 208963
Kansas City, Kansas, United States
University of Kentucky Chandler Medical Center /ID# 207603
Lexington, Kentucky, United States
Massachusetts General Hospital /ID# 207993
Boston, Massachusetts, United States
...and 55 more locations
Hematocrit (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Hemoglobin (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Neutrophils (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Lymphocytes (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Monocytes (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, and 52
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, and 52
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, and 52
pH (Urinalysis): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time frame: Baseline, Weeks 6, 26, 39, and 52
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 1 (postdose), Weeks 6 and 52
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
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.
Time frame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 6, 13, 26, 39, and 52
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 6, 13, 26, 39, and 52
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
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.
Time frame: Baseline, Weeks 6, 13, 26, 39, and 52