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ClinicalTrial.gov Identifier : NCT03781167

A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

    Status Recruiting
    Related Conditions
    Parkinson's Disease (PD)

Enrollment Details

130 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type III phase trial.

Protocol ID
M15-741

Brief summary

Top

The purpose of this study is to assess the safety and tolerability of ABBV-951 in subjects with Parkinson's disease (PD).

Participant Attributes :
  • Male and Female
  • Ages 30 Years and more

Canada: 5

0
Calgary, AB
1
Toronto, ON
2
Montreal, QC
3
Quebec City, QC
4
Quebec City, QC
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Study Design

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    None (Open Label)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Subjects with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa -responsive
    • Subjects must be judged by the investigator to be inadequately controlled by current therapy, have recognizable
      identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day
    • Subject is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study.
    • Subject is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

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