Phase 3 N=244 Treatment

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

Parkinson's Disease (PD)

Bottom Line

View on ClinicalTrials.gov: NCT03781167 ↗

Enrolled (actual)

244

Serious AEs

25.8%

Results posted

Oct 2023

Primary outcome: Primary: Number of Participants With Adverse Events — 121; 109; 230; 32 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ABBV-951 (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	121; 109; 230; 32; 31; 63	—
PRIMARY Number of Participants With Adverse Events of Special Interest	42; 44; 86; 103; 97; 200	—
PRIMARY 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	10; 15; 25	—
PRIMARY Hematocrit (Hematology): Change From Baseline to End of Study	-0.02; -0.02; -0.02; -0.01; -0.02; -0.02	—
PRIMARY Hemoglobin (Hematology): Change From Baseline to End of Study	-5.00; -6.82; -5.89; -5.42; -4.48; -4.98	—
PRIMARY Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study	-0.15; -0.21; -0.18; -0.12; -0.13; -0.13	—
PRIMARY White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study	0.02; 0.32; 0.17; 0.12; 0.22; 0.17	—
PRIMARY Neutrophils (Hematology): Change From Baseline to End of Study	0.01; 0.33; 0.17; -0.03; 143.08; 67.25	—
PRIMARY Lymphocytes (Hematology): Change From Baseline to End of Study	0.06; -0.07; 0.00; 0.09; 13.92; 6.59	—
PRIMARY Monocytes (Hematology): Change From Baseline to End of Study	0.01; 0.01; 0.01; 0.02; 17.43; 8.21	—
PRIMARY Absolute Platelet Count (Hematology): Change From Baseline to End of Study	4.59; 0.39; 2.54; -1.68; -10.39; -5.74	—
PRIMARY Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study	-0.09; -0.15; -0.12; -0.38; 0.05; -0.18	—
PRIMARY Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study	2.15; 1.78; 1.97; -1.30; 2.17; 0.31	—
PRIMARY Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study	0.03; -0.09; -0.03; -0.08; -0.36; -0.20	—
PRIMARY Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study	-0.27; 0.55; 0.13; -0.02; 0.48; 0.20	—
PRIMARY Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study	0.02; -0.01; 0.00; 0.21; 0.17; 0.19	—
PRIMARY Creatinine (Clinical Chemistry): Change From Baseline to End of Study	-4.45; -5.67; -5.04; -2.71; -4.07; -3.33	—
PRIMARY Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study	2.52; -11.01; -4.01; 5.61; -15.44; -3.83	—
PRIMARY Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study	-0.85; -0.15; -0.51; -0.43; 0.28; -0.11	—
PRIMARY Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study	-8.94; -11.28; -10.07; -8.95; -11.66; -10.16	—
PRIMARY Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study	-1.89; -2.21; -2.05; -0.69; -2.56; -1.52	—
PRIMARY Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study	-6.57; -8.58; -7.55; -1.66; -4.91; -3.14	—
PRIMARY Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study	-1.07; -3.13; -2.06; -1.47; -5.02; -3.07	—
PRIMARY Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study	-1.91; -4.56; -3.19; 1.68; -2.86; -0.39	—
PRIMARY Sodium (Clinical Chemistry): Change From Baseline to End of Study	-0.52; -1.06; -0.78; -0.35; -1.26; -0.76	—
PRIMARY Potassium (Clinical Chemistry): Change From Baseline to End of Study	-0.02; -0.08; -0.05; 0.01; 0.00; 0.00	—
PRIMARY Calcium (Clinical Chemistry): Change From Baseline to End of Study	-0.02; -0.04; -0.03; -0.03; -0.04; -0.03	—
PRIMARY Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study	0.08; 0.08; 0.08; 0.09; 0.09; 0.09	—
PRIMARY Uric Acid (Clinical Chemistry): Change From Baseline to End of Study	-28.36; -37.43; -32.73; -16.66; -32.91; -24.01	—
PRIMARY Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study	-0.37; -0.57; -0.47; -0.19; -0.31; -0.25	—
PRIMARY Albumin (Clinical Chemistry): Change From Baseline to End of Study	-1.65; -1.95; -1.79; -1.31; -1.14; -1.23	—
PRIMARY Glucose (Clinical Chemistry): Change From Baseline to End of Study	-0.39; -0.39; -0.39; -0.37; -0.14; -0.27	—
PRIMARY Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study	1.19; 0.97; 1.09; 0.77; 0.28; 0.55	—
PRIMARY Magnesium (Clinical Chemistry): Change From Baseline to End of Study	-0.03; -0.03; -0.03; -0.03; -0.02; -0.02	—
PRIMARY Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study	-0.08; 0.00; -0.04; -0.17; -0.17	—
PRIMARY Homocysteine (Clinical Chemistry): Change From Baseline to End of Study	3.07; 6.70; 4.79; 4.22; 6.69; 5.32	—
PRIMARY Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study	0.30; 4.68; 2.38; -4.50; 14.10; 3.86	—
PRIMARY Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study	-229.58; -206.30; -218.53; -147.38; -143.30; -145.53	—
PRIMARY pH (Urinalysis): Change From Baseline to End of Study	0.07; 0.19; 0.13; 0.20; 0.24; 0.22	—
PRIMARY Specific Gravity (Urinalysis): Change From Baseline to End of Study	0.00; 0.00; 0.00; 0.00; 0.00; 0.00	—
PRIMARY Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study	-1.5; 3.5; 0.9; -1.5; 2.6; 0.5	—
PRIMARY Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study	-1.9; -0.7; -1.3; 0.0; -0.6; -0.3	—
PRIMARY Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study	-1.5; -1.8; -1.6; -0.5; 0.2; -0.1	—
PRIMARY Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study	2.1; 2.2; 2.1; -2.3; -2.2; -2.2	—
PRIMARY Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study	0.4; -0.1; 0.2; 0.5; 1.1; 0.8	—
PRIMARY Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study	-2.3; -0.8; -1.6; -0.5; 1.6; 0.5	—
PRIMARY Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study	-5.3; -4.2; -4.8; 6.4; 6.4; 6.4	—
PRIMARY Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study	1.2; 2.0; 1.6; 1.0; 0.6; 0.8	—
PRIMARY Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study	-1.0; -0.2; -0.6; 3.1; 2.6; 2.9	—
PRIMARY Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study	-30.7; -28.3; -29.6; 22.6; 26.1; 24.2	—
SECONDARY Average Daily Normalized "Off" Time: Change From Baseline to End of Study	-2.04; -1.84; -1.95; -2.43; -2.36; -2.40	<0.001 sig
SECONDARY Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study	-0.00; 0.11; 0.05; -0.56; -0.23; -0.41	>0.999
SECONDARY Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study	2.04; 1.74; 1.90; 2.99; 2.60; 2.81	<0.001 sig
SECONDARY Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study	-2.6; -1.8; -2.3; -2.6; -3.3; -2.9	<0.001 sig
SECONDARY Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study	-2.8; -1.2; -2.1; -3.6; -3.9; -3.7	<0.001 sig
SECONDARY Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study	-0.6; -0.8; -0.7; 2.0; 3.8; 2.8	=0.4447
SECONDARY Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study	-1.8; -1.1; -1.5; -1.7; -1.7; -1.7	<0.001 sig
SECONDARY Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study	-5.0; -7.3; -6.1; -6.9; -8.2; -7.5	<0.001 sig
SECONDARY Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study	-7.0; -8.4; -7.6; -8.3; -8.2; -8.3	<0.001 sig
SECONDARY The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study	0.060; 0.113; 0.085; 0.064; 0.122; 0.090	=0.0035 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03781167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.