Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT04380142|
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : October 14, 2021
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. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations.
ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951 plus oral placebo (does not contain treatment drug). In the second arm, participants will be given placebo solution and LD/CD tablets. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world.
In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. 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 Drug: Placebo for Levodopa/Carbidopa (LD/CD) Drug: Levodopa/Carbidopa (LD/CD) Drug: Placebo for ABBV-951||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||174 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients|
|Actual Study Start Date :||October 19, 2020|
|Actual Primary Completion Date :||September 3, 2021|
|Actual Study Completion Date :||September 28, 2021|
Experimental: ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)
Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) and oral placebo for LD/CD for 12 weeks
Solution for continuous subcutaneous infusion (CSCI)
Drug: Placebo for Levodopa/Carbidopa (LD/CD)
Active Comparator: Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951
Participants will receive oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks
Drug: Levodopa/Carbidopa (LD/CD)
Oral encapsulated tablet
Drug: Placebo for ABBV-951
Solution for continuous subcutaneous infusion (CSCI)
- Change in "On" Time (Hours) Without Troublesome Dyskinesia [ Time Frame: Baseline (Week 0) Up to Week 12 ]"On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the Parkinson's Disease (PD) Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.
- Change in "Off" Time (Hours) [ Time Frame: Baseline (Week 0) Up to Week 12 ]"Off" time is assessed by the PD Diary.
- Change in Motor Experiences of Daily Living [ Time Frame: Baseline (Week 0) Up to Week 12 ]Motor Experiences of Daily Living is assessed by Part II of Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 52.
- Early Morning "Off" Status [ Time Frame: At Week 12 ]Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.
- Change in Average Daily Normalized "On" Time (Hours) Without Dyskinesia [ Time Frame: Baseline (Week 0) Up to Week 12 ]"On" time without dyskinesia is assessed based on the Parkinson's Disease (PD) Diary.
- Change in Sleep Symptoms [ Time Frame: Baseline (Week 0) Up to Week 12 ]Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.
- Change in Quality of Life Assessed by PD Questionnaire-39 item (PDQ-39) [ Time Frame: Baseline (Week 0) Up to Week 12 ]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.
- Change in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L) [ Time Frame: Baseline (Week 0) Up to Week 12 ]EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of health related quality of life that can be used in a wide range of health conditions and treatments.
- Change in PD Symptoms as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device [ Time Frame: Baseline (Week 0) Up to Week 12 ]PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence.
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): NCT04380142
|Study Director:||ABBVIE INC.||AbbVie|