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
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : May 7, 2020
Last Update Posted : December 27, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson's Disease (PD) | Drug: ABBV-951 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 130 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | June 8, 2020 |
| Estimated Primary Completion Date : | June 27, 2025 |
| Estimated Study Completion Date : | June 27, 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: ABBV-951
Solution for continuous subcutaneous infusion (CSCI).
Other Names:
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- 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.
- 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.
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.
| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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): NCT04379050
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| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT04379050 |
| Other Study ID Numbers: |
M15-737 2019-004235-23 ( EudraCT Number ) |
| First Posted: | May 7, 2020 Key Record Dates |
| Last Update Posted: | December 27, 2022 |
| Last Verified: | December 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/ |
| 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 |
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Parkinson's Disease (PD) ABBV-951 Levodopa/Carbidopa (LD/CD) Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) |
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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 |