Clinical trial NCT03362879: COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
Official title: COSMOS - COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease (PD)
Keywords: Advanced Parkinson's Disease
Levodopa-Carbidopa Intestinal Gel (LCIG)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-12-05
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
timeFrame: 12 months
measure: Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation
timeFrame: 12 months
measure: Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
timeFrame: 12 months
measure: HCRU: Caregiver Support by Number of Participants
timeFrame: 12 months
measure: Percentage of Physicians With Overall Preference for LCIG Monotherapy
timeFrame: 12 months
measure: Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
timeFrame: 12 months
measure: Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
timeFrame: 12 months
measure: Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2
timeFrame: 12 months
measure: Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
timeFrame: 12 months
measure: Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment
timeFrame: 12 months
measure: Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy
timeFrame: 12 months
measure: Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Hermagor-Pressegger See
country: Austria
facility: Gailtal Klinik /ID# 202505
state: Kaernten
city: Graz
country: Austria
facility: Medizinische Universität Graz /ID# 202559
state: Steiermark
city: Calgary
country: Canada
facility: University of Calgary /ID# 206550
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital /ID# 169448
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital /ID# 169038
state: Ontario
city: Lévis
country: Canada
facility: Clinique Neuro Levis /ID# 206549
state: Quebec
city: Zagreb
country: Croatia
facility: Clinical Hosp Center Zagreb /ID# 203553
city: Brno 2
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne /ID# 209774
state: Brno-mesto
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc /ID# 209776
state: Olomoucky Kraj
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice /ID# 209775
city: Athens
country: Greece
facility: Aiginiteio University Hospital /ID# 203476
state: Attiki
city: Athens
country: Greece
facility: HYGEIA Hospital /ID# 203474
city: Glyfada
country: Greece
facility: Mediterraneo Hospital /ID# 203472
city: Ioannina
country: Greece
facility: University Hospital of Ioannin /ID# 203471
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem /ID# 170026
state: Pecs
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 170025
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei /ID# 170027
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem /ID# 170028
city: Cork
country: Ireland
facility: Bon Secours Hospital /ID# 168424
city: Galway
country: Ireland
facility: University Hospital Galway /ID# 170754
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 167542
state: Tel-Aviv
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 167543
city: Bucharest
country: Romania
facility: Clinic Fundeni Institute /ID# 169265
state: Bucuresti
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital /ID# 169263
city: Targu Mures
country: Romania
facility: Emergency Clinical County Hosp /ID# 169269
city: Timisoara
country: Romania
facility: Timisoara County /ID# 169266
city: Timisoara
country: Romania
facility: Timisoara County /ID# 169268
city: Madrid
country: Spain
facility: AbbVie Farmaceutica SLU /ID# 164364
city: Stockholm
country: Sweden
facility: Centrum for neurologi /ID# 171391
city: Stockholm
country: Sweden
facility: Neurologmottagningen /ID# 171390
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Kovacs N, Szasz J, Vela-Desojo L, Svenningsson P, Femia S, Parra JC, Sanchez-Solino 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 Dec;105:139-144. doi: 10.1016/j.parkreldis.2022.08.002. Epub 2022 Aug 17.