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COSMOS

COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel (COSMOS)

    Status Recruiting
    Related Conditions
    Parkinson's Disease (PD)

Enrollment Details

28 Worldwide Enrollment Goal

Phases: 

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

This is a type IV phase trial.

Protocol ID
P16-831

Brief summary

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The purpose of this study is to evaluate treatment of advanced Parkinson's Disease (PD) patients on levodopa-carbidopa intestinal gel (LCIG) monotherapy in a routine clinical setting.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 5

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

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

    Cohort

  • The relationship between the observation period and the time of patient enrollment. Time perspective can be prospective: looking forward using periodic observations usually collected following patient enrollment, or retrospective: looking back using observations usually collected prior to patient selection and enrollment.
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    Time Perspective

    Cross-Sectional

    • Patients diagnosed with APD and on LCIG treatment for at least 12 months
    • Patient must have been on continuous LCIG treatment for at least 80% of days in the preceding year
    • Patients must be treated by the same physician (PI or co-investigator) since the initiation of LCIG treatment
    • Participation in a concurrent or a previous interventional clinical trial during which the patient was on LCIG therapy
    • Lack of motivation or insufficient language skills to complete the study questionnaires

More on this trial

Clinical Trials.gov