Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04379050
Previous Study | Return to List | Next Study

Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease

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: NCT04379050
Recruitment Status : Enrolling by invitation
First Posted : May 7, 2020
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 1, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE June 8, 2020
Estimated Primary Completion Date January 21, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
  • Percentage of Participants With Adverse Events (AE) [ Time Frame: Up To Week 96 ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. 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 (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study.
  • Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale [ Time Frame: Up To Week 96 ]
    The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").
  • Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale [ Time Frame: Up To Week 96 ]
    The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").
  • Change in Clinical Laboratory Test Data [ Time Frame: Up To Week 96 ]
    Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.
  • Change in Vital Signs Measurements [ Time Frame: Up To Week 96 ]
    Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
  • Change From Baseline in Electrocardiograms (ECGs) [ Time Frame: Up To Week 96 ]
    Change from baseline in 12-lead ECGs on heart rte, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • Percentage of Participants With Adverse Events (AE) [ Time Frame: Up To Week 96 ]
    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the tuse of the study drug or device as either reasonable possibility or no reasonable possibility. 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 (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study.
  • Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale [ Time Frame: Up To Week 96 ]
    The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").
  • Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale [ Time Frame: Up To Week 96 ]
    The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").
  • Change in Clinical Laboratory Test Data [ Time Frame: Up To Week 96 ]
    Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.
  • Change in Vital Signs Measurements [ Time Frame: Up To Week 96 ]
    Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
  • Change From Baseline in Electrocardiograms (ECGs) [ Time Frame: Up To Week 96 ]
    Change from baseline in 12-lead ECGs on heart rte, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • Average Normalized Daily "Off" Time [ Time Frame: Up To Week 96 ]
    Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
  • Average Normalized Daily "On" Time [ Time Frame: Up To Week 96 ]
    Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
  • Parkinson's Disease (PD) Symptoms Measurement [ Time Frame: Up To Week 96 ]
    PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV. The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.
  • Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) [ Time Frame: Up To Week 96 ]
    Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. Each item is scored on a 5-point scale.
  • Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L) [ Time Frame: Up To Week 96 ]
    Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS).
  • Cognitive Impairment Measurement [ Time Frame: Up To Week 96 ]
    Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
Official Title  ICMJE An Open-label Extension of Study M15-741 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

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.

ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.

Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily for 96 weeks or until premature discontinuation.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

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 continuous subcutaneous infusion (CSCI).
Other Names:
  • Foscarbidopa
  • Foslevodopa
Study Arms  ICMJE Experimental: ABBV-951
Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for 96 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: May 6, 2020)
121
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 21, 2025
Estimated Primary Completion Date January 21, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
  • Participants willing and able to comply with procedures required in the protocol.

Exclusion Criteria:

- Participants, if judged by the investigator to be unsuitable candidates to continue 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,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04379050
Other Study ID Numbers  ICMJE M15-737
2019-004235-23 ( 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.: Yes
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 December 2020

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