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INSIGHTS Study

A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)

    Status Recruiting
    Related Conditions
    Advanced Parkinson's Disease

Enrollment Details

88 Worldwide Enrollment Goal

Phases: 

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

This is a type III phase trial.

Protocol ID
M12-927

Brief summary

Top

The primary objective of this study is to examine the effect of Levodopa-Carbidopa Intestinal Gel (LCIG) relative to that of OMT on non-motor symptoms associated with Parkinson's disease (PD).

Participant Attributes :
  • Male and Female
  • Ages 30 Years to 99 Years

Canada: 3

0
Edmonton, AB
1
Ottawa, ON
2
Toronto, ON
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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

    Parallel

  • 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

    • Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.
    • Participant(s) demonstrates persistent motor fluctuations in spite of individually optimized treatment.
    • The participant's Parkinson's disease is levodopa-responsive.
    • Participant(s) has had optimized treatment with available anti-PD medication and their motor symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
    • Male or female participant(s) must be at least 30 years of age.
    • Participant's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD.
    • Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
    • Known hypersensitivity to levodopa, carbidopa or radiopaque material.
    • Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma).
    • Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator.

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