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Trial record 1 of 1 for:    NCT04380142
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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

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: NCT04380142
Recruitment Status : Completed
First Posted : May 8, 2020
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE May 6, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date October 14, 2021
Actual Study Start Date  ICMJE October 19, 2020
Actual Primary Completion Date September 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • 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.
  • 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.
  • 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 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 MDS-UPDRS Tool Part I [ Time Frame: Baseline (Week 0) Up to Week 12 ]
    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 in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III [ Time Frame: Baseline (Week 0) Up to Week 12 ]
    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 in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV [ Time Frame: Baseline (Week 0) Up to Week 12 ]
    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 in PD Symptoms as Assessed by the MDS-UPDRS Tool Total Score of Parts I - III [ Time Frame: Baseline (Week 0) Up to Week 12 ]
    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 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease (PD)
Intervention  ICMJE
  • Drug: ABBV-951
    Solution for continuous subcutaneous infusion (CSCI)
  • Drug: Placebo for Levodopa/Carbidopa (LD/CD)
    Oral capsule
  • Drug: Levodopa/Carbidopa (LD/CD)
    Oral encapsulated tablet
  • Drug: Placebo for ABBV-951
    Solution for continuous subcutaneous infusion (CSCI)
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: ABBV-951
    • 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
    Interventions:
    • Drug: Levodopa/Carbidopa (LD/CD)
    • Drug: Placebo for 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 Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2021)
174
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2020)
130
Actual Study Completion Date  ICMJE September 28, 2021
Actual Primary Completion Date September 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
  • Participants must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD) equivalents and be judged by the investigator to have motor symptoms inadequately controlled by current therapy, have a recognizable/identifiable "Off" and "On" states (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3 consecutive PD Diary days with a minimum of 2 hours each day.
  • Participant or caregiver, if applicable, demonstrates the understanding and correct use of the delivery system, including the insertion of the cannula into the participant's abdomen, as assessed by the investigator or designee during the Screening period.

Exclusion Criteria:

  • Clinically significant, unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
  • History of allergic reaction or significant sensitivity to LD or constituents of the study drug (and its excipients) and/or other products in the same class.
  • Has known active Coronavirus Disease - 2019 (COVID-19) infection.
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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04380142
Other Study ID Numbers  ICMJE M15-736
2019-003930-18 ( 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
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date October 2021

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