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A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment

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ClinicalTrials.gov Identifier: NCT03374917
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson's Disease (PD) Drug: ABBV-951 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : February 25, 2019
Estimated Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABBV-951
ABBV-951 administered by continuous subcutaneous infusion (CSCI) for 4 weeks.
Drug: ABBV-951
powder for solution




Primary Outcome Measures :
  1. Percentage of Participants with Infusion Site Reactions [ Time Frame: 28 Days ]
    Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.

  2. Number of Participants with Adverse Events [ Time Frame: From first dose of study drug to 30 days after last dose of study drug (up to 2 months) ]
    Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.

  3. Percentage of Participants with Markedly Abnormal Vital Signs Values [ Time Frame: 28 days ]
    Vital signs will be collected both supine and standing.

  4. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 28 days ]
    The C-SSRS is an instrument designed to assess suicidal behavior and ideation.

  5. Percentage of Participants with Potentially Clinically Significant Laboratory Values [ Time Frame: 28 days ]
    Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.

  6. Percentage of Participants with Potentially Clinically Significant Electrocardiogram (ECG) Results [ Time Frame: 28 days ]
    A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.


Secondary Outcome Measures :
  1. Plasma Concentrations of Levodopa [ Time Frame: Days 1, 7, 14, 21, and 28 ]
    Blood samples for pharmacokinetic assessment will be collected twice at each visit.



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with a diagnosis of definite idiopathic Parkinson's disease (PD) that is levodopa-responsive according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
  • Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before enrollment in this study.
  • Subject is judged inadequately controlled on current therapy in the opinion of the Investigator and must experience a minimum of 2.5 hours of "off" time per day prior to Enrollment.
  • Subjects with a MMSE score greater than or equal to 24 and considered by the Investigator to not have dementia.

Exclusion Criteria:

  • Subjects with clinically significant electrocardiogram (ECG) values.
  • History of significant skin conditions or disorders that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
  • Receipt of an investigational product within at least 6 weeks prior to study drug administration.
  • Subjects with moderate to severe kidney disease.
  • Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
  • Patient/caregiver that cannot demonstrate proper use of the devices (drug pump and wearable device) will not be allowed to participate.

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): NCT03374917


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
United States, Arizona
Banner Sun Health Res Inst /ID# 165840 Recruiting
Sun City, Arizona, United States, 85351
United States, California
Loma Linda University /ID# 165592 Recruiting
Loma Linda, California, United States, 92354
Univ CA, Irvine Med Ctr /ID# 165594 Not yet recruiting
Orange, California, United States, 92868
United States, Florida
Compass Research /ID# 167329 Recruiting
Orlando, Florida, United States, 32806
United States, Kansas
Univ Kansas Med Ctr /ID# 166280 Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky Chandler Medical Center /ID# 164407 Recruiting
Lexington, Kentucky, United States, 40536
University of Louisville /ID# 164997 Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University-School of Medicine /ID# 164412 Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Medical Center /ID# 164924 Recruiting
New York, New York, United States, 10016-6402
United States, Ohio
University of Cincinnati /ID# 165142 Not yet recruiting
Cincinnati, Ohio, United States, 45267-0585
Cleveland Clinic Foundation /ID# 164413 Recruiting
Cleveland, Ohio, United States, 44195
United States, Texas
Neurology Consultants of Dallas /ID# 167116 Recruiting
Dallas, Texas, United States, 75231-3831
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03374917     History of Changes
Other Study ID Numbers: M15-739
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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.: No

Keywords provided by AbbVie:
carbidopa
levodopa

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases