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Trial record 2 of 2 for:    M15-736
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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

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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

Study Description
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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.


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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: ABBV-951
Solution for continuous subcutaneous infusion (CSCI)

Drug: Placebo for Levodopa/Carbidopa (LD/CD)
Oral capsule
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in "Off" Time (Hours) [ Time Frame: Baseline (Week 0) Up to Week 12 ]
    "Off" time is assessed by the PD Diary.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04380142    
Other Study ID Numbers: M15-736
2019-003930-18 ( EudraCT Number )
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
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 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
Statistical Analysis Plan (SAP)
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

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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
Keywords provided by AbbVie:
Parkinson's Disease (PD)
ABBV-951
Levodopa/Carbidopa (LD/CD)
Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)
Additional relevant MeSH terms:
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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
Levodopa
 Carbidopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors