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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03362879
• Date of registration: 30/11/2017
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel COSMOS
• Scientific title: COSMOS - COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
• Date of first enrolment: December 14, 2017
• Target sample size: 412
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03362879
• Study type: Observational

Countries of recruitment

Austria, Canada, Croatia, Czechia, Greece, Hungary, Ireland, Israel, Romania, Spain, Sweden

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease (PD)

Primary Outcome(s)

Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months [Time Frame: 12 months]

Secondary Outcome(s)

HCRU: Caregiver Support by Number of Participants [Time Frame: 12 months]

Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants [Time Frame: 12 months]

Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation [Time Frame: 12 months]

Percentage of Physicians With Overall Preference for LCIG Monotherapy [Time Frame: 12 months]

Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country [Time Frame: 12 months]

Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) [Time Frame: 12 months]

Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication [Time Frame: 12 months]

Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment [Time Frame: 12 months]

Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2 [Time Frame: 12 months]

Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation [Time Frame: 12 months]

Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy [Time Frame: 12 months]

Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation) [Time Frame: 12 months]

Secondary ID(s)

P16-831

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03362879