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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT03781167
• Date of registration: 18/12/2018
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD)
• Scientific title: 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
• Date of first enrolment: April 29, 2019
• Target sample size: 244
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03781167
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Russian Federation, Spain, Sweden, United Kingdom, United States

Contacts

• Name: ABBVIE INC.
• Affiliation: AbbVie

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease (PD)

Intervention(s)

Drug: ABBV-951

Primary Outcome(s)

Activated partial thromboplastin time (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Glucose (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Glucose (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Percentage of subjects 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 [Time Frame: up to 52 weeks]

Uric acid (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

White blood cell (WBC) count (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Hematocrit (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Ketones (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Mean corpuscular hemoglobin (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Blood (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Lymphocytes (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Percentage of Participants with Abnormal Electrocardiogram (ECG) Results [Time Frame: up to 52 weeks]

Prothrombin time (PT) (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Neutrophils (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Sodium (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Adverse Events [Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)]

Absolute platelet count (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Adverse Events of Special Interest [Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks)]

Creatine phosphokinase (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Bilirubin (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Hemoglobin (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Creatinine clearance (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Albumin (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Serum glutamic-oxaloacetic transaminase (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Alkaline phosphatase (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Gamma-glutamyl transpeptidase (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Mean corpuscular volume concentration (MCHC) (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Calcium (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

pH (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Red Blood Cell (RBC) Count (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Blood urea nitrogen (BUN) (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Specific gravity (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Total bilirubin (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Lactate dehydrogenase (LDH) (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Cholesterol (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Monocytes (Hematology): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Potassium (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Creatinine (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Serum glutamic pyruvic transaminase (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Inorganic phosphorus (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Protein (Urinalysis): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Pulse rate (Vital Signs): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Vitamin B6 (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Blood pressure (Vital Signs): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Homocysteine (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Magnesium (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Sodium bicarbonate/CO2 (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Vitamin B12 (Clinical Chemistry): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Secondary Outcome(s)

Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Average normalized daily "Off" time and "On" times: Change from Baseline to end of study [Time Frame: up to 52 weeks]

Quality of Life Assessed by EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score: Change from Baseline to End of Study [Time Frame: up to 52 weeks]

Sleep symptoms as assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2): Change from Baseline to end of study [Time Frame: up to 52 weeks]

Parkinson's Disease (PD) symptoms: Change from Baseline to end of study [Time Frame: up to 52 weeks]

Secondary ID(s)

M15-741

2018-002144-85

Source(s) of Monetary Support

Please refer to primary and secondary sponsors