We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04380142
Previous Study | Return to List | Next Study

Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04380142
Recruitment Status : Completed
First Posted : May 8, 2020
Results First Posted : November 18, 2022
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease (PD)
Interventions Drug: ABBV-951
Drug: Placebo for Levodopa/Carbidopa (LD/CD)
Drug: Levodopa/Carbidopa (LD/CD)
Drug: Placebo for ABBV-951
Enrollment 174
Recruitment Details  
Pre-assignment Details Enrolled participants entered an open-label oral Levodopa/Carbidopa (LD/CD) Stabilization Period of 14 to 21 days, at the end of which, eligible participants were randomized 1:1 to 12 weeks of treatment with either: 24-hour/day continuous subcutaneous infusion (CSCI) of ABBV-951 + oral placebo capsules for LD/CD immediate-release (IR) or 24-hour/day CSCI of placebo solution for ABBV-951 + encapsulated LD/CD IR tablets in a 12-week Double-Blind Treatment Period.
Arm/Group Title LD/CD Stabilization Period LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description The dose and schedule of oral LD/CD were adjusted over the first 7 to 14 days by the investigator to achieve the best possible control of the participant's motor symptoms; that included using nighttime dosing if needed and was agreed upon by the participant and the investigator. Once stabilized, no further adjustments to oral LD/CD IR were to be made for at least 7 days prior to randomization. Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks. Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Period Title: LD/CD Stabilization Period
Started 174 0 0
Completed 145 0 0
Not Completed 29 0 0
Reason Not Completed
Adverse Event             3             0             0
Withdrawal by Subject             4             0             0
Lost to Follow-up             1             0             0
Lack of Efficacy             1             0             0
Difficulty With Drug Delivery System             2             0             0
Other, Not Specified             18             0             0
Period Title: Double-Blind Treatment Period
Started [1] 0 69 76
Randomized and Treated 0 67 74
Completed 0 62 48
Not Completed 0 7 28
Reason Not Completed
Adverse Event             0             1             14
Withdrew Consent             0             3             6
Lack of Efficacy             0             0             2
Difficulty With Drug Delivery System             0             1             3
Other, Not Specified             0             0             1
Did Not Receive Study Drug             0             2             2
[1]
Number Randomized
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD Total
Hide Arm/Group Description Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks. Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 67 74 141
Hide Baseline Analysis Population Description
Safety Analysis Set: All participants who received any dose of study drug during the Double-Blind Treatment Period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 74 participants 141 participants
66.6  (9.82) 66.3  (9.20) 66.4  (9.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 74 participants 141 participants
Female
18
  26.9%
24
  32.4%
42
  29.8%
Male
49
  73.1%
50
  67.6%
99
  70.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 74 participants 141 participants
Hispanic or Latino
1
   1.5%
4
   5.4%
5
   3.5%
Not Hispanic or Latino
66
  98.5%
70
  94.6%
136
  96.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 74 participants 141 participants
American Indian or Alaska Native
0
   0.0%
1
   1.4%
1
   0.7%
Asian
3
   4.5%
0
   0.0%
3
   2.1%
Native Hawaiian or Other Pacific Islander
1
   1.5%
1
   1.4%
2
   1.4%
Black or African American
2
   3.0%
2
   2.7%
4
   2.8%
White
61
  91.0%
70
  94.6%
131
  92.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Averaged Normalized On Time Without Troublesome Dyskinesia   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Normalized hours
Number Analyzed 67 participants 73 participants 140 participants
9.49  (2.619) 9.20  (2.423) 9.34  (2.514)
[1]
Measure Description: "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the Parkinson's Disease (PD) Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.
[2]
Measure Analysis Population Description: Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment.
1.Primary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Troublesome Dyskinesia
Hide Description "On" time is defined as periods of good motor symptom control, and was assessed by the Parkinson's Disease (PD) diary. The normalized "On" time without troublesome dyskinesia is the sum of the normalized "On" time without dyskinesia and the normalized "On" time with non-troublesome dyskinesia. "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the PD Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 62 47
Least Squares Mean (Standard Error)
Unit of Measure: hours
0.97  (0.50) 2.72  (0.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0083
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean of Difference
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
0.46 to 3.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.65
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "Off" Time (Hours)
Hide Description "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness and was assessed by the PD Diary.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 62 47
Least Squares Mean (Standard Error)
Unit of Measure: hours
-0.96  (0.49) -2.75  (0.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0054
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.79
Confidence Interval (2-Sided) 95%
-3.03 to -0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.63
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score
Hide Description The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of PD. MDS-UPDRS is multimodal scale assessing impairment and disability. Part II assesses the participant's motor experiences of daily living 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.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 62 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.06  (0.79) -2.65  (0.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1318
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.58
Confidence Interval (2-Sided) 95%
-3.65 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.05
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Early Morning "Off" Status (Morning Akinesia) at Week 12 of the Double-Blind Treatment Period
Hide Description

Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up at Week 12, based on the first morning symptom upon awakening on the last valid PD Diary day at Week 12.

"Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness and was assessed by the PD Diary.

Time Frame Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with an assessment for morning akinesia at Week 12.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 60 47
Measure Type: Number
Unit of Measure: percentage of participants
63.3 17.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <=0.001
Comments The generalized linear mixed model: status = treatment country visit baseline treatment*visit. The unstructured variance-covariance structure is used.
Method generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.04 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.49
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Average Daily Normalized "On" Time Without Dyskinesia (Hours)
Hide Description

"On" time is defined as periods of good motor symptom control, and was assessed by the PD diary. The normalized "On" time without dyskinesia is defined as the hours of average daily normalized "On" time without dyskinesia as assessed by the PD Diary (normalized to a 16-hour waking day averaged over 3 consecutive days).

Baseline value is defined as the average of normalized "On" time without dyskinesia collected over the 3 PD Diary days before randomization.

Time Frame Baseline, Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 62 47
Least Squares Mean (Standard Error)
Unit of Measure: hours
1.32  (0.53) 3.13  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method generalized linear mixed model
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
0.46 to 3.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.68
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score
Hide Description The PDSS-2 addresses PD-specific sleep disturbances such as restless leg syndrome (RLS), morning akinesia, pain, and sleep apnea. 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]). Scores are calculated for each of the 3 domains (motor symptoms at night, PD symptoms at night, and disturbed sleep) 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.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with an assessment for PDSS-2.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-2.52  (1.12) -7.92  (1.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <=0.001
Comments ANCOVA model including effects for treatment, country, and baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -5.40
Confidence Interval (2-Sided) 95%
-8.03 to -2.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.32
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Quality of Life Assessed by Parkinson's Disease Questionnaire 39 Item (PDQ-39) Summary Index Score
Hide Description The PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. It evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. Data from the PDQ-39 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).
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with an assessment for PDQ-39.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 45
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-2.28  (1.75) -6.38  (1.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0470
Comments ANCOVA model including effects for treatment, country, and baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean of Difference
Estimated Value -4.10
Confidence Interval (2-Sided) 95%
-8.14 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.04
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Summary Index
Hide Description The 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 subject'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 (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with an assessment for EQ-5D-5L.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.002  (0.021) 0.051  (0.022)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0566
Comments ANCOVA model including effects for treatment, country, and baseline.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value 0.049
Confidence Interval (2-Sided) 95%
-0.001 to 0.100
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.025
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Bradykinesia Score (BK50) as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device
Hide Description The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a bradykinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as BK50. A higher score indicates worse bradykinesia (there is no prespecified range of scores). The BK50 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment for BK50 score.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 66
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.34  (0.52) 1.38  (0.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value 1.72
Confidence Interval (2-Sided) 95%
0.30 to 3.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Interquartile Range of Bradykinesia Score (BK75-BK25) as Assessed by the PKG Wearable Device
Hide Description The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a bradykinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as BK50 (there is no prespecified range of scores). BK75-BK25 is the difference between the third quartile (BK75) and first quartile (BK25) bradykinesia scores, and this interquartile range is a measure of variability of bradykinesia. A higher score indicates a higher degree of variability in bradykinesia scores. The BK75 and BK 25 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment for BK75-BK25.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 66
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.13  (0.49) 0.31  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7989
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-1.20 to 1.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Median Dyskinesia Score (DK50) as Assessed by the PKG Wearable Device
Hide Description The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a dyskinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as DK50. A higher score indicates worse dyskinesia (there is no prespecified range of scores). The DK50 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment for DK50.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 66
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
1.02  (1.38) -1.71  (1.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1656
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -2.73
Confidence Interval (2-Sided) 95%
-6.61 to 1.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.96
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to Week 12 of the Double-Blind Treatment Period in Interquartile Range of Dyskinesia Score (DK75-DK25) as Assessed by the PKG Wearable Device
Hide Description The PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence. For each participant, the PKG watch collected data continuously and an algorithm calculated a dyskinesia score every 2 minutes between 9am-6pm across multiple days. Among these scores for this participant at this visit, the median of all the score values is defined as DK50 (there is no prespecified range of scores). DK75-DK25 is the difference between the third quartile (DK75) and first quartile (DK25) dyskinesia scores, and this interquartile range is a measure of variability of dyskinesia. A higher score indicates a higher degree of variability in dyskinesia scores. The DK75 and DK25 scores for all participants across all visits were then analyzed with mixed-effect model for repeated measures (MMRM) and the LS mean (model-based mean) was obtained from the model.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all randomized participants who received any dose of study drug during the Double-Blind Treatment Period and who had baseline and at least 1 post-baseline observation for at least 1 efficacy assessment. Participants with a baseline and Week 12 assessment for DK75-DK25.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 59 66
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
2.72  (2.59) -2.77  (2.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LD/CD + Placebo for ABBV-951, ABBV-951 + Placebo for LD/CD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1347
Comments The model included fixed categorical effects of treatment, country and visit, baseline-by-visit and treatment-by-visit interactions, and baseline as a covariate. An unstructured variance-covariance matrix was used.
Method Repeated measures model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -5.49
Confidence Interval (2-Sided) 95%
-12.71 to 1.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.65
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Irritation Grade Numeric Grade >= 5 or Letter Grade >= D on the Infusion Site Irritation Scale Across All Study Post-Baseline Visits
Hide Description The investigator or qualified designee evaluated the infusion site area (abdomen). A 2-part (numeric and letter grading) evaluation scale was used to assess irritation. Irritation - Numeric Grades: 0 = No evidence of irritation; 1 = Minimal erythema, barely perceptible; 2 = Moderate erythema, readily visible; or minimal edema, or minimal papular response; 3 = Erythema and papules; 4 = Definite edema; 5 = Erythema, edema, and papules; 6 = Vesicular eruption; 7 = Strong reaction spreading beyond the test site. Irritation - Letter Grades: A = No finding; B = Slight glazed appearance; C = Marked glazing; D = Glazing with peeling and cracking; E = Glazing with fissures; F = Film of dried serous exudates covering all or portion of the patch site; G = Small petechial erosions and/or scabs.
Time Frame Day 2 up to Week 12 of the double-blind treatment period plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received any dose of study drug during the Double-Blind Treatment Period.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 67 74
Measure Type: Count of Participants
Unit of Measure: Participants
At Least 1 Observation of Numeric Grade >= 5 0 10
At Least 1 Observation of Letter Grade >= D 0 6
At Least 1 Observation of Numeric Grade >= 5 or Letter Grade >= D 0 10
At Least 1 Observation of Numeric Grade >= 5 and Letter Grade >= D 0 6
14.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Oral LD/CD Stabilization Period
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. An AE, whether associated with study drug or not, meeting any of the following criteria is considered a serious AE (SAE): results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent a serious outcome. The severity of each AE is rated as mild, moderate, or severe, and having either a reasonable possibility or no reasonable possibility of relationship to study drug. Events were considered treatment emergent if they arose after the first dose of study drug.
Time Frame From first dose of stabilization period treatment up to the first dose of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Oral LD/CD Analysis Set: all participants who received at least 1 dose of open label CD/LD IR tablets during the Oral CD/LD Stabilization Period.
Arm/Group Title LD/CD Stabilization Period
Hide Arm/Group Description:
The dose and schedule of oral LD/CD were adjusted over the first 7 to 14 days by the investigator to achieve the best possible control of the participant's motor symptoms; that included using nighttime dosing if needed and was agreed upon by the participant and the investigator. Once stabilized, no further adjustments to oral LD/CD IR were to be made for at least 7 days prior to randomization.
Overall Number of Participants Analyzed 174
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
41
  23.6%
Any Severe TEAE
3
   1.7%
Any TEAE Considered Related to Study Drug
2
   1.1%
Any TEAE Considered Associated With COVID-19 Infection
0
   0.0%
Any TEAE Leading to Premature Discontinuation of Study Drug
3
   1.7%
Any TEAE Leading Death
0
   0.0%
Any Serious TEAE
4
   2.3%
Deaths Related to COVID-19
0
   0.0%
15.Secondary Outcome
Title Number of Participants With TEAEs During the Double-Blind Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. An AE, whether associated with study drug or not, meeting any of the following criteria is considered an SAE: results in death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent a serious outcome. The severity of each AE is rated as mild, moderate, or severe, and having either a reasonable possibility or no reasonable possibility of relationship to study drug. Adverse events of special interest include polyneuropathy, weight loss, somnolence, hallucinations/psychosis. Events were considered treatment emergent if they arose after the first dose of study drug.
Time Frame From first dose of double-blind treatment up to Week 12 of the double-blind treatment period plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received any dose of study drug during the Double-Blind Treatment Period.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 67 74
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
42
  62.7%
63
  85.1%
Any Serious TEAE
4
   6.0%
6
   8.1%
Any TEAE Leading to Death
1
   1.5%
0
   0.0%
Any TEAE Leading to Study Drug Discontinuation
1
   1.5%
16
  21.6%
Any Severe TEAE
1
   1.5%
7
   9.5%
Any TEAE Considered Related to Study Drug
15
  22.4%
52
  70.3%
Any Serious TEAE Considered Related With Infusion Pump
0
   0.0%
3
   4.1%
All Deaths (Includes Non-Treatment-Emergent Deaths)
1
   1.5%
0
   0.0%
Deaths Related to COVID-19
0
   0.0%
0
   0.0%
Any Adverse Event of Special Interest
25
  37.3%
59
  79.7%
16.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Changes From Baseline in Hematology, Chemistry, Urinalysis, Special Laboratory Parameters, Vital Signs, and Electrocardiograms (ECGs)
Hide Description Measures analyzed for prespecified potentially clinically significant criteria: hematology (hematocrit, hemoglobin, red blood cells, white blood cells, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume concentration, prothrombin time, activated partial thromboplastin time), laboratory (blood urea nitrogen, creatinine, creatine phosphokinase, bilirubin, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, phosphorus, uric acid, total protein, albumin, glucose, sodium bicarbonate, chloride, triglycerides, cholesterol, magnesium), special lab criteria (vitamin B12, vitamin B6, folate, homocysteine, methylmalonic acid), vital signs (diastolic and systolic blood pressure, pulse rate), ECG (heart rate, PR, and QTcF interval), urinalysis (specific gravity, ketones, pH, protein, glucose, blood, bilirubin).
Time Frame Screening up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received any dose of study drug during the Double-Blind Treatment Period.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 67 74
Measure Type: Count of Participants
Unit of Measure: Participants
Hematology
0
   0.0%
0
   0.0%
Chemistry
0
   0.0%
0
   0.0%
Urinalysis
0
   0.0%
0
   0.0%
Special Laboratory Parameters
0
   0.0%
0
   0.0%
Vital Signs
0
   0.0%
0
   0.0%
ECGs
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Affirmative Responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) Across All Study Post-Baseline Visits During the Double-Blind Treatment Period
Hide Description The C-SSRS is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.
Time Frame Screening up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received any dose of study drug during the Double-Blind Treatment Period. Participants with an assessment for C-SSRS.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 67 74
Measure Type: Count of Participants
Unit of Measure: Participants
Participants With Any Suicidal Ideations
2
   3.0%
5
   6.8%
Participants With Any Suicidal Behaviors
0
   0.0%
0
   0.0%
Participants With Any Suicidal Behaviors or Ideations
2
   3.0%
5
   6.8%
Participants With Non-Suicidal Self-Injurious Behavior
0
   0.0%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With a Subscore > 5 For Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Ration Scale (QUIP-RS) at Any Time During the Double-Blind Treatment Period
Hide Description The QUIP-RS measures the severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. QUIP-RS subscores include gambling (score 0 to 16), sex (score 0 to 16), buying (score 0 to 16), eating (score 0 to 16), hobbyism-punding (score 0 to 32), and PD medication use (score 0 to 16). Higher scores represent a worse outcome.
Time Frame Baseline (Week 0) up to Week 12 of the double-blind treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received any dose of study drug during the Double-Blind Treatment Period. Participants with at least 1 post-baseline value for the specific QUIP-RS subscore.
Arm/Group Title LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description:
Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks.
Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
Overall Number of Participants Analyzed 65 67
Measure Type: Count of Participants
Unit of Measure: Participants
Impulse Control Disorder: Buying Score
3
   4.6%
3
   4.5%
Impulse Control Disorder: Eating Score
5
   7.7%
6
   9.0%
Impulse Control Disorder: Gambling Score
2
   3.1%
0
   0.0%
Impulse Control Disorder: Sex Score
6
   9.2%
4
   6.0%
Additional Disorder: Hobbyism Punding Score
12
  18.5%
7
  10.4%
Additional Disorder: PD Medication Use Score
5
   7.7%
6
   9.0%
Time Frame CD/LD Stabilization Period: From Screening (All-Cause Mortality) or first dose of stabilization period treatment (Serious/Other Adverse Events) up to the first dose of the double-blind treatment period. Double-Blind Treatment Period: From Screening (All-Cause Mortality) or first dose of double-blind treatment (Serious/Other Adverse Events) up to Week 12 of the double-blind treatment period plus 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LD/CD Stabilization Period LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Hide Arm/Group Description The dose and schedule of oral LD/CD were adjusted over the first 7 to 14 days by the investigator to achieve the best possible control of the participant's motor symptoms; that included using nighttime dosing if needed and was agreed upon by the participant and the investigator. Once stabilized, no further adjustments to oral LD/CD IR were to be made for at least 7 days prior to randomization. Participants received oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks. Participants received ABBV-951 by CSCI and oral placebo for LD/CD for 12 weeks.
All-Cause Mortality
LD/CD Stabilization Period LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/174 (0.00%)      1/67 (1.49%)      0/74 (0.00%)    
Hide Serious Adverse Events
LD/CD Stabilization Period LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/174 (2.30%)      4/67 (5.97%)      6/74 (8.11%)    
Gastrointestinal disorders       
GASTROOESOPHAGEAL REFLUX DISEASE  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
General disorders       
CHEST PAIN  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
Infections and infestations       
ACUTE HEPATITIS B  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
COVID-19 PNEUMONIA  1  0/174 (0.00%)  0 1/67 (1.49%)  1 0/74 (0.00%)  0
CATHETER SITE CELLULITIS  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
CELLULITIS  1  0/174 (0.00%)  0 1/67 (1.49%)  1 0/74 (0.00%)  0
INFUSION SITE CELLULITIS  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
Injury, poisoning and procedural complications       
CONTUSION  1  0/174 (0.00%)  0 1/67 (1.49%)  1 0/74 (0.00%)  0
FALL  1  0/174 (0.00%)  0 1/67 (1.49%)  1 0/74 (0.00%)  0
Metabolism and nutrition disorders       
DEHYDRATION  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
HYPOPHAGIA  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
Nervous system disorders       
MIGRAINE  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
PARKINSONISM  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
PARKINSONISM HYPERPYREXIA SYNDROME  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
Psychiatric disorders       
DELUSION  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
PARANOIA  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
PSYCHOTIC DISORDER  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
Renal and urinary disorders       
NEPHROLITHIASIS  1  0/174 (0.00%)  0 1/67 (1.49%)  1 0/74 (0.00%)  0
Reproductive system and breast disorders       
PROSTATOMEGALY  1  0/174 (0.00%)  0 0/67 (0.00%)  0 1/74 (1.35%)  1
Respiratory, thoracic and mediastinal disorders       
ACUTE RESPIRATORY FAILURE  1  0/174 (0.00%)  0 1/67 (1.49%)  1 0/74 (0.00%)  0
DIAPHRAGM MUSCLE WEAKNESS  1  1/174 (0.57%)  1 0/67 (0.00%)  0 0/74 (0.00%)  0
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LD/CD Stabilization Period LD/CD + Placebo for ABBV-951 ABBV-951 + Placebo for LD/CD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/174 (8.62%)      18/67 (26.87%)      51/74 (68.92%)    
Gastrointestinal disorders       
CONSTIPATION  1  2/174 (1.15%)  2 0/67 (0.00%)  0 4/74 (5.41%)  4
General disorders       
INFUSION SITE BRUISING  1  1/174 (0.57%)  1 2/67 (2.99%)  2 6/74 (8.11%)  6
INFUSION SITE ERYTHEMA  1  0/174 (0.00%)  0 1/67 (1.49%)  1 20/74 (27.03%)  33
INFUSION SITE HAEMORRHAGE  1  1/174 (0.57%)  1 0/67 (0.00%)  0 6/74 (8.11%)  8
INFUSION SITE INDURATION  1  0/174 (0.00%)  0 0/67 (0.00%)  0 4/74 (5.41%)  5
INFUSION SITE NODULE  1  0/174 (0.00%)  0 0/67 (0.00%)  0 6/74 (8.11%)  8
INFUSION SITE OEDEMA  1  0/174 (0.00%)  0 0/67 (0.00%)  0 9/74 (12.16%)  15
INFUSION SITE PAIN  1  0/174 (0.00%)  0 1/67 (1.49%)  1 19/74 (25.68%)  29
INFUSION SITE PRURITUS  1  0/174 (0.00%)  0 0/67 (0.00%)  0 4/74 (5.41%)  5
PERIPHERAL SWELLING  1  0/174 (0.00%)  0 0/67 (0.00%)  0 4/74 (5.41%)  4
Infections and infestations       
INFUSION SITE CELLULITIS  1  0/174 (0.00%)  0 0/67 (0.00%)  0 13/74 (17.57%)  14
INFUSION SITE INFECTION  1  0/174 (0.00%)  0 0/67 (0.00%)  0 4/74 (5.41%)  4
Injury, poisoning and procedural complications       
FALL  1  6/174 (3.45%)  7 11/67 (16.42%)  14 6/74 (8.11%)  7
Nervous system disorders       
BALANCE DISORDER  1  1/174 (0.57%)  1 0/67 (0.00%)  0 4/74 (5.41%)  4
DYSKINESIA  1  5/174 (2.87%)  5 4/67 (5.97%)  4 8/74 (10.81%)  8
ON AND OFF PHENOMENON  1  2/174 (1.15%)  2 0/67 (0.00%)  0 6/74 (8.11%)  6
Psychiatric disorders       
HALLUCINATION  1  0/174 (0.00%)  0 1/67 (1.49%)  1 5/74 (6.76%)  5
HALLUCINATION, VISUAL  1  0/174 (0.00%)  0 0/67 (0.00%)  0 4/74 (5.41%)  5
1
Term from vocabulary, MedDRA 24.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 1-800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04380142    
Other Study ID Numbers: M15-736
2019-003930-18 ( EudraCT Number )
First Submitted: May 6, 2020
First Posted: May 8, 2020
Results First Submitted: August 16, 2022
Results First Posted: November 18, 2022
Last Update Posted: November 18, 2022