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

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: NCT03781167
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2018
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE April 29, 2019
Estimated Primary Completion Date July 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • Adverse Events [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ]
    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. 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.
  • Adverse Events of Special Interest [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ]
    Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed
  • 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 ]
    The Infusion Site Evaluation Scale will be used to assess infusion sites.
  • Hematocrit (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Hemoglobin (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Red Blood Cell (RBC) Count (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • White blood cell (WBC) count (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Neutrophils (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Lymphocytes (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Monocytes (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Absolute platelet count (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Mean corpuscular hemoglobin (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Mean corpuscular volume concentration (MCHC) (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Prothrombin time (PT) (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Activated partial thromboplastin time (Hematology): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Blood urea nitrogen (BUN) (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Creatinine (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Creatine phosphokinase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Total bilirubin (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Serum glutamic pyruvic transaminase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Serum glutamic-oxaloacetic transaminase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Lactate dehydrogenase (LDH) (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Gamma-glutamyl transpeptidase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Alkaline phosphatase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Sodium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Potassium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Calcium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Inorganic phosphorus (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Uric acid (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Cholesterol (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Albumin (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Glucose (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Sodium bicarbonate/CO2 (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Magnesium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Creatinine clearance (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Vitamin B6 (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Vitamin B12 (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Homocysteine (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Specific gravity (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Ketones (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • pH (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Protein (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Glucose (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Blood (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Bilirubin (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Blood pressure (Vital Signs): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for vital signs.
  • Pulse rate (Vital Signs): Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    The change from baseline to end of study will be assessed for vital signs.
  • Percentage of Participants with Abnormal Electrocardiogram (ECG) Results [ Time Frame: up to 52 weeks ]
    ECG recordings will be evaluated as 'normal' or 'abnormal'.
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • Adverse Events [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ]
    Treatment emergent adverse events defined as any adverse event from the initiation of CSCI through 30 days after last infusion device is removed
  • Adverse Events of Special Interest [ Time Frame: From initiation of CSCI through 30 days after last infusion device is removed (up to 56 weeks) ]
    Treatment emergent adverse events of special interest defined as any adverse event of polyneuropathy or weight loss from the initiation of CSCI through 30 days after last infusion device is removed
  • 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 56 weeks ]
    The Infusion Site Evaluation Scale will be used to assess infusion sites.
  • Hematocrit (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Hemoglobin (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Red Blood Cell (RBC) Count (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • White blood cell (WBC) count (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Neutrophils (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Lymphocytes (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Monocytes (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Absolute platelet count (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Mean corpuscular hemoglobin (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Mean corpuscular volume concentration (MCHC) (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Prothrombin time (PT) (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Activated partial thromboplastin time (Hematology): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Blood urea nitrogen (BUN) (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Creatinine (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Creatine phosphokinase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Total bilirubin (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Serum glutamic pyruvic transaminase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Serum glutamic-oxaloacetic transaminase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Lactate dehydrogenase (LDH) (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Gamma-glutamyl transpeptidase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Alkaline phosphatase (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Sodium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Potassium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Calcium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Inorganic phosphorus (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Uric acid (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Cholesterol (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Albumin (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Glucose (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Sodium bicarbonate/CO2 (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Magnesium (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Creatinine clearance (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Vitamin B6 (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Vitamin B12 (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Homocysteine (Clinical Chemistry): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Specific gravity (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Ketones (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • pH (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Protein (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Glucose (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Blood (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Bilirubin (Urinalysis): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for clinical laboratory tests.
  • Blood pressure (Vital Signs): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for vital signs.
  • Pulse rate (Vital Signs): Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    The change from baseline to end of study will be assessed for vital signs.
  • Percentage of Participants with Abnormal Electrocardiogram (ECG) Results [ Time Frame: up to 56 weeks ]
    ECG recordings will be evaluated as 'normal' or 'abnormal'.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2021)
  • Average normalized daily "Off" time and "On" times: Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    Average normalized daily "Off" time and "On" times as assessed by the Parkinson's Disease (PD) Diary.
  • Parkinson's Disease (PD) symptoms: Change from Baseline to end of study [ Time Frame: up to 52 weeks ]
    PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available).
  • 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 ]
    The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
  • 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 ]
    The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD.
  • 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 ]
    The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2018)
  • Average normalized daily "Off" time and "On" times: Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    Average normalized daily "Off" time and "On" times as assessed by the Parkinson's Disease (PD) Diary.
  • Parkinson's Disease (PD) symptoms: Change from Baseline to end of study [ Time Frame: up to 56 weeks ]
    PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS- UPDRS) Parts I-IV (or the Unified Parkinson's Disease Rating Scale [UPDRS] Parts I-V where a validated translation of the MDS-UPDRS is not available).
  • 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 56 weeks ]
    The PDQ-39 is used to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
  • 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 56 weeks ]
    The PDSS-2 is used to characterize the various aspects of nocturnal sleep problems in patients with PD.
  • Quality of Life Assessed by Parkinson's Disease Questionnaire (PDQ-39) Score: Change from Baseline to End of Study [ Time Frame: up to 56 weeks ]
    The PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.
  • 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 56 weeks ]
    The EQ-5D-5L is a standardized instrument used to measure health-related quality of life that can be used in a wide range of health conditions and treatments.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD)
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the safety and tolerability of ABBV-951 in participants with Parkinson's disease (PD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease (PD)
Intervention  ICMJE Drug: ABBV-951
solution for infusion
Other Names:
  • Foscarbidopa
  • Foslevodopa
Study Arms  ICMJE Experimental: ABBV-951
Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 52 weeks.
Intervention: Drug: ABBV-951
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 29, 2021)		 240
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2018)		 130
Estimated Study Completion Date  ICMJE July 4, 2022
Estimated Primary Completion Date July 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   Germany,   Italy,   Japan,   Netherlands,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT03781167
Other Study ID Numbers  ICMJE M15-741
2018-002144-85 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP