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

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ClinicalTrials.gov Identifier: NCT03362879
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease
Parkinson's Disease (PD)

Detailed Description:
Patients with advanced Parkinson's Disease who have been prescribed LCIG for at least 12 months will be entered into the study cohort. Clinical data will be collected by retrospective review of the patient's medical records as well as a single study visit for current data. Treatment of the patients and follow up will be according to the physician's judgment, regional regulations and the product monograph.

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Study Type : Observational
Actual Enrollment : 394 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: COSMOS - COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : December 17, 2018
Actual Study Completion Date : December 17, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Advanced Parkinson's Disease
Patients with advanced Parkinson's Disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.



Primary Outcome Measures :
  1. Percentage of patients on Levodopa-Carbidopa Intestinal Gel (LCIG) monotherapy from LCIG initiation to 12 months [ Time Frame: 12 months ]
    The percentage of patients on LCIG monotherapy from immediately following LCIG initiation to 12 months


Secondary Outcome Measures :
  1. The percentage of patients on LCIG monotherapy from immediately following LCIG initiation to 12 months in participating countries with at least 20 subjects enrolled [ Time Frame: 12 months ]
    The percentage of patients on LCIG monotherapy from immediately following LCIG initiation to 12 months.

  2. Time from initial LCIG administration to the initiation of LCIG monotherapy [ Time Frame: 12 months ]
    The time from the initiation of LGIC therapy to the initiation of LCIG as monotherapy.

  3. Time from initial LCIG administration to the introduction or tapering of each PD medication or substantial dose adjustments. [ Time Frame: 12 months ]
    The time from the initial LCIG administration to the introduction or tapering of each PD medication or substantial dose adjustments.

  4. Overall Preference for pharmacological treatment approach [ Time Frame: 12 months ]
    The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by of the physician and the patient/caregiver.

  5. LCIG infusion settings [ Time Frame: 12 months ]
    Final LCIG settings upon completion of initial titration.

  6. Substantial LCIG dose adjustments [ Time Frame: 12 months ]
    The percentage of patients with substantial LCIG dose adjustments.

  7. Time from initial LCIG administration to the introduction or tapering of each PD medication or substantial dose adjustments in participating countries with at least 20 subjects enrolled. [ Time Frame: 12 months ]
    The time from initial LCIG administration to the introduction or tapering of each PD medication or substantial dose adjustments.

  8. HCRU in participating countries with at least 20 subjects enrolled. [ Time Frame: 12 months ]
    The HCRU questionnaire is used to assess healthcare resource utilization, including occupational status, nursing home visits, hospitalizations/emergency care visits and reason, caregiver support, and patient´s opinion on Parkinson's Disease medication.

  9. Parkinson's Disease (PD) medication management [ Time Frame: 12 months ]
    Medication management for PD from immediately prior to LCIG initiation to 12 months.

  10. Healthcare resource utilization questionnaire (HCRU) [ Time Frame: 12 months ]
    The HCRU questionnaire is used to assess healthcare resource utilization, including occupational status, nursing home visits, hospitalizations/emergency care visits and reason, caregiver support, and patient´s opinion on PD medication.

  11. Predictors for achieving long-term therapy [ Time Frame: 12 months ]
    Patient and physician profiles will be used to identify predictors for achieving long-term monotherapy with LCIG compared with LCIG plus add-on PD medication.

  12. Duration of LCIG monotherapy [ Time Frame: 12 months ]
    The mean duration of LCIG monotherapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Advanced Parkinson's Disease (APD), on current treatment with levodopa-carbidopa intestinal gel (LCIG), and treated with LCIG for at least 12 months prior to enrollment.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03362879


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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03362879     History of Changes
Other Study ID Numbers: P16-831
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Advanced Parkinson's Disease
Levodopa-Carbidopa Intestinal Gel (LCIG)

Additional relevant MeSH terms:
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Carbidopa
Carbidopa, levodopa drug combination
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists