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Completed

NCT Number: NCT03374917

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

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).

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Banner Sun Health Res Inst /ID# 165840, Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-951

Drug

powder for solution

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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