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

AbbVie

Status: Completed

Conditions: Parkinson's Disease (PD)

Study type: Observational

Funder types: Industry

Identifiers

NCT03362879

P16-831

Details and patient eligibility

About

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.

Full description

Participants 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 participant's medical records as well as a single study visit for current data. Treatment of the participants and follow up will be according to the physician's judgment, regional regulations and the product monograph.

Enrollment: 412 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed with APD and on LCIG treatment for at least 12 months
• Participant must have been on continuous LCIG treatment for at least 80% of days in the preceding year
• Participants must be treated by the same physician (principal investigator or co-investigator) since the initiation of LCIG treatment

Exclusion criteria

• Participation in a concurrent or a previous interventional clinical trial during which the participant was on LCIG therapy
• Lack of motivation or insufficient language skills to complete the study questionnaires

Trial design

412 participants in 1 patient group

Participants with advanced Parkinson's disease

Description:

Participants with advanced Parkinson's disease on current treatment with levodopa-carbidopa intestinal gel (LCIG) for at least 12 months.