Clinical trial

A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease

Name

M15-741

Description

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.

Trial arms

Trial start

2019-04-29

Estimated PCD

2022-08-17

Trial end

2022-08-17

Status

Completed

Phase

Early phase I

Treatment

ABBV-951

Solution for continuous subcutaneous infusion (CSCI)

Arms:

ABBV-951 High Dose Subgroup, ABBV-951 Low Dose Subgroup

Other names:

Foslevodopa/Foscarbidopa

Size

244

Primary endpoint

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)

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)

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

Hematocrit (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Hemoglobin (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Neutrophils (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Lymphocytes (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Monocytes (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Absolute Platelet Count (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Creatinine (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Sodium (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Potassium (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Calcium (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Uric Acid (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Albumin (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Glucose (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Magnesium (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Homocysteine (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, and 52

Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, and 52

Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study

Baseline, Weeks 6, 26, and 52

pH (Urinalysis): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

Specific Gravity (Urinalysis): Change From Baseline to End of Study

Baseline, Weeks 6, 26, 39, and 52

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 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 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)

Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study

Baseline, Day 1 (postdose), Weeks 6 and 52

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 244, 'type': 'ACTUAL'}}

Updated at

2023-10-23

1 organization

1 product

1 indication

Organization

AbbVie

Product

ABBV-951

Indication

Parkinson's Disease