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

• ClinicalTrials.gov Identifier: NCT04379050
• Recruitment Status: Active, not recruiting
• First Posted: May 7, 2020
• Last Update Posted: December 27, 2022
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: May 1, 2020
• First Posted Date: May 7, 2020
• Last Update Posted Date: December 27, 2022
• Actual Study Start Date: June 8, 2020
• Estimated Primary Completion Date: June 27, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2022)

• 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 rate, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.

Original Primary Outcome Measures (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.

Current Secondary Outcome Measures (submitted: October 26, 2022)

• 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 (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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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 during the Primary Treatment Period and during the optional Extended Treatment Period.

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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Parkinson's Disease (PD)

Intervention

Drug: ABBV-951

Solution for continuous subcutaneous infusion (CSCI).

Other Names:

• Foscarbidopa
• Foslevodopa

Study Arms

Experimental: ABBV-951

Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.

Intervention: Drug: ABBV-951

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 26, 2022): 130
• Original Estimated Enrollment (submitted: May 6, 2020): 121
• Estimated Study Completion Date: June 27, 2025
• Estimated Primary Completion Date: June 27, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russian Federation, Spain, Sweden, United Kingdom, United States

Administrative Information

• NCT Number: NCT04379050
• Other Study ID Numbers: 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

• 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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: December 2022