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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (PD)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 412

Contacts and Locations

Study Locations

• Austria
  • Kaernten
    • Hermagor-Pressegger See, Kaernten, Austria, 9620
      • Gailtal Klinik /ID# 202505
  • Steiermark
    • Graz, Steiermark, Austria, 8010
      • Medizinische Universität Graz /ID# 202559
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary /ID# 206550
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital /ID# 169448
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital /ID# 169038
  • Quebec
    • Lévis, Quebec, Canada, G6W 0M5
      • Clinique Neuro Levis /ID# 206549
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hosp Center Zagreb /ID# 203553
• Czechia
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice /ID# 209775
  • Brno-mesto
    • Brno 2, Brno-mesto, Czechia, 602 00
      • Fakultni nemocnice u sv. Anny v Brne /ID# 209774
  • Olomoucky Kraj
    • Olomouc, Olomoucky Kraj, Czechia, 779 00
      • Fakultni Nemocnice Olomouc /ID# 209776
• Greece
  • Athens, Greece, 15123
    • HYGEIA Hospital /ID# 203474
  • Glyfada, Greece, 16675
    • Mediterraneo Hospital /ID# 203472
  • Ioannina, Greece, 45500
    • University Hospital of Ioannin /ID# 203471
  • Attiki
    • Athens, Attiki, Greece, 11528
      • Aiginiteio University Hospital /ID# 203476
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem /ID# 170025
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei /ID# 170027
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem /ID# 170028
  • Pecs
    • Pécs, Pecs, Hungary, 7624
      • Pecsi Tudomanyegyetem /ID# 170026
• Ireland
  • Cork, Ireland, T12 DV56
    • Bon Secours Hospital /ID# 168424
  • Galway, Ireland, H91 YR71
    • University Hospital Galway /ID# 170754
• Israel
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center /ID# 167543
  • Tel-Aviv
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Ctr /ID# 167542
• Romania
  • Bucharest, Romania, 20125
    • Colentina Clinical Hospital /ID# 169263
  • Targu Mures, Romania, 540042
    • Emergency Clinical County Hosp /ID# 169269
  • Timisoara, Romania, 300736
    • Timisoara County /ID# 169266
  • Timisoara, Romania, 300736
    • Timisoara County /ID# 169268
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 022328
      • Clinic Fundeni Institute /ID# 169265
• Spain
  • Madrid, Spain
    • AbbVie Farmaceutica SLU /ID# 164364
• Sweden
  • Stockholm, Sweden, 113 65
    • Centrum for neurologi /ID# 171391
  • Stockholm, Sweden, 171 76
    • Neurologmottagningen /ID# 171390

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months	The percentage of participants on LCIG monotherapy from immediately following LCIG initiation to 12 months. LCIG monotherapy means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation	LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2). PD medications were captured by time point and category from the initiation of LCIG therapy until the introduction of each add-on PD medication taken. Categories included levodopa, catechol-O-methyltransferase (COMT) inhibitors,dopamine agonist (excluding apomorphine), monoamine oxidase (MAO) inhibitor, n-methyl-d-aspartate receptor (NMDA) antagonist, apomorphine, anticholinergics, surgical therapy, or other. Participants may have initiated more than one PD medication or category.	12 months
Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation	Physicians were asked to document the LCIG infusion details at 12 months after LCIG initiation, including the total daily dose. Total dose per day was calculated as morning dose + continuous dose x duration of infusion + extra dose. Abbreviations: ml = milliliters.	12 months
Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants	The HCRU questionnaire is used to assess healthcare resource utilization. Participants were asked about their occupational status (primary occupation), caregiver support (change in amount of caregiver help needed with daily activities/home care), and participant´s opinion on Parkinson's disease medication (number of pills in addition to LCIG the participant was willing to take each day). Physicians were asked to report details regarding participant visits and hospital admissions in the 12 months prior to the study visit.	12 months
HCRU: Caregiver Support by Number of Participants	The HCRU questionnaire is used to assess healthcare resource utilization. Participants were asked about their occupational status (primary occupation), caregiver support (change in amount of caregiver help needed with daily activities/home care), and participant´s opinion on Parkinson's disease medication (number of pills in addition to LCIG the participant was willing to take each day). Physicians were asked to report details regarding participant visits and hospital admissions in the 12 months prior to the study visit.	12 months
Percentage of Physicians With Overall Preference for LCIG Monotherapy	The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by the physician.	12 months
Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)	LCIG monotherapy 1 means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point. The influence of predefined variables was evaluated using multivariable logistic regression models. The target variables were analyzed using two different sets of potential predictors: one set containing participant data and one set containing site and physician data.	12 months
Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)	LCIG monotherapy 1 means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point. The influence of predefined variables was evaluated using multivariable logistic regression models. The target variables were analyzed using two different sets of potential predictors: one set containing participant data and one set containing site and physician data. Physician data in table shown as "average frequency of routine visits" includes average frequency of routine visits for advanced Parkinson's disease (APD) participants on device aided therapy ≥3x/years.	12 months
Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2	LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2). Duration of LCIG monotherapy was calculated for all participants who reached the respective monotherapy as time from LCIG initiation until LCIG is given as a monotherapy (separately for monotherapy 1 and monotherapy 2 definition).	12 months
Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country	Time for substantial change was determined as the time from LCIG initiation until the first substantial dose change in days 12 months after LCIG initiation. A substantial change was defined as a change of at least 20% compared to the LCIG dose at LCIG initiation.	12 months
Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment	Time for substantial change was determined as the time from LCIG initiation until the first substantial dose change in days 12 months after LCIG initiation. A substantial change was defined as a change of at least 20% compared to the LCIG dose at LCIG initiation.	12 months
Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy	Time (in days) from LCIG initiation until monotherapy was calculated for those participants who were not on monotherapy (i.e., needed additional PD medication during LCIG infusion) at LCIG initiation, but reached monotherapy during the study. LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).	12 months
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication	LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1). The number of days for tapering process is the number of days between maximum and minimum daily dose; participants with minimum (or maximum, respectively) daily dose not at the end of the tapering process were checked. A maximum duration of approximately 2 months of the tapering process was allowed (otherwise the tapering process was set to missing).	12 months

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Kovács N, Szász J, Vela-Desojo L, Svenningsson P, Femia S, Parra JC, Sanchez-Soliño O, Bergmann L, Gurevich T, Fasano A. Motor and nonmotor symptoms in patients treated with 24-hour daily levodopa-carbidopa intestinal gel infusion: Analysis of the COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS). Parkinsonism Relat Disord. 2022 Aug 17. pii: S1353-8020(22)00255-3. doi: 10.1016/j.parkreldis.2022.08.002. [Epub ahead of print]

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Actual): December 17, 2018
• Study Completion (Actual): December 17, 2018

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Advanced Parkinson's Disease; Levodopa-Carbidopa Intestinal Gel (LCIG)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P16-831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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