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

Parkinson's Disease (PD) Clinical Trial

— COSMOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03362879
• Other study ID #: P16-831
• Status: Completed
• Start date: December 14, 2017
• Est. completion date: December 17, 2018

Study information

• Verified date: December 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: December 17, 2018
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz /ID# 202559	Graz	Steiermark
Austria	Gailtal Klinik /ID# 202505	Hermagor-Pressegger See	Kaernten
Canada	University of Calgary /ID# 206550	Calgary	Alberta
Canada	Clinique Neuro Levis /ID# 206549	Lévis	Quebec
Canada	Ottawa Hospital /ID# 169448	Ottawa	Ontario
Canada	Toronto Western Hospital /ID# 169038	Toronto	Ontario
Croatia	Clinical Hosp Center Zagreb /ID# 203553	Zagreb
Czechia	Fakultni nemocnice u sv. Anny v Brne /ID# 209774	Brno 2	Brno-mesto
Czechia	Fakultni Nemocnice Olomouc /ID# 209776	Olomouc	Olomoucky Kraj
Czechia	Vseobecna Fakultni Nemocnice /ID# 209775	Prague
Greece	Aiginiteio University Hospital /ID# 203476	Athens	Attiki
Greece	HYGEIA Hospital /ID# 203474	Athens
Greece	Mediterraneo Hospital /ID# 203472	Glyfada
Greece	University Hospital of Ioannin /ID# 203471	Ioannina
Hungary	Semmelweis Egyetem /ID# 170025	Budapest
Hungary	Borsod-Abauj-Zemplen Megyei /ID# 170027	Miskolc
Hungary	Pecsi Tudomanyegyetem /ID# 170026	Pécs	Pecs
Hungary	Szegedi Tudomanyegyetem /ID# 170028	Szeged
Ireland	Bon Secours Hospital /ID# 168424	Cork
Ireland	University Hospital Galway /ID# 170754	Galway
Israel	Sheba Medical Center /ID# 167543	Ramat Gan
Israel	Tel Aviv Sourasky Medical Ctr /ID# 167542	Tel Aviv-Yafo	Tel-Aviv
Romania	Clinic Fundeni Institute /ID# 169265	Bucharest	Bucuresti
Romania	Colentina Clinical Hospital /ID# 169263	Bucharest
Romania	Emergency Clinical County Hosp /ID# 169269	Targu Mures
Romania	Timisoara County /ID# 169266	Timisoara
Romania	Timisoara County /ID# 169268	Timisoara
Spain	AbbVie Farmaceutica SLU /ID# 164364	Madrid
Sweden	Centrum for neurologi /ID# 171391	Stockholm
Sweden	Neurologmottagningen /ID# 171390	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Related Info