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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 : Completed
First Posted : December 19, 2018
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and tolerability of ABBV-951 in participants with Parkinson's disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: ABBV-951 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 29, 2019
Actual Primary Completion Date : August 17, 2022
Actual Study Completion Date : August 17, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABBV-951
Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 52 weeks.
 Drug: ABBV-951
solution for infusion
Other Names:
  • Foscarbidopa
  • Foslevodopa


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. Percentage of Participants with Abnormal Electrocardiogram (ECG) Results [ Time Frame: up to 52 weeks ]
    ECG recordings will be evaluated as 'normal' or 'abnormal'.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781167


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03781167    
Other Study ID Numbers: M15-741
2018-002144-85 ( EudraCT Number )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
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, analyses plans, 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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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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
Keywords provided by AbbVie:
Parkinson's Disease (PD)
ABBV-951
Levodopa/Carbidopa
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases