Parkinson's Disease (PD)COSMOSNCT03362879
COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
An observational study of Parkinson's Disease (PD), run by AbbVie at 30 sites in 11 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- How many people
- 412 participants
- Where
- 30 sitesin 11 countries
- Study dates
- 14 Dec 2017to 17 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
30 sites in 11 countries.
30 sites in 11 countries
Romania5 sites
Clinic Fundeni Institute /ID# 169265
Bucharest, Bucharest, 022328
Colentina Clinical Hospital /ID# 169263
Bucharest, 20125
Emergency Clinical County Hosp /ID# 169269
Târgu Mureş, 540042
Timisoara County /ID# 169266
Timișoara, 300736
Timisoara County /ID# 169268
Timișoara, 300736
Canada4 sites
University of Calgary /ID# 206550
Calgary, Alberta, T2N 4Z6
Clinique Neuro Levis /ID# 206549
Lévis, Quebec, G6W 0M5
Ottawa Hospital /ID# 169448
Ottawa, Ontario, K1Y 4E9
Toronto Western Hospital /ID# 169038
Toronto, Ontario, M5T 2S8
Greece4 sites
Aiginiteio University Hospital /ID# 203476
Athens, Attica, 11528
HYGEIA Hospital /ID# 203474
Athens, 15123
Mediterraneo Hospital /ID# 203472
Glyfada, 16675
University Hospital of Ioannin /ID# 203471
Ioannina, 45500
Hungary4 sites
Semmelweis Egyetem /ID# 170025
Budapest, 1083
Borsod-Abauj-Zemplen Megyei /ID# 170027
Miskolc, 3526
Pecsi Tudomanyegyetem /ID# 170026
Pécs, Pecs, 7624
Szegedi Tudomanyegyetem /ID# 170028
Szeged, 6720
Czechia3 sites
Fakultni nemocnice u sv. Anny v Brne /ID# 209774
Brno, Brno-mesto, 602 00
Fakultni Nemocnice Olomouc /ID# 209776
Olomouc, Olomouc Region, 779 00
Vseobecna Fakultni Nemocnice /ID# 209775
Prague, 128 08
Austria2 sites
Medizinische Universität Graz /ID# 202559
Graz, Styria, 8010
Gailtal Klinik /ID# 202505
Hermagor-Pressegger See, Carinthia, 9620
Ireland2 sites
Bon Secours Hospital /ID# 168424
Cork, T12 DV56
University Hospital Galway /ID# 170754
Galway, H91 YR71
Israel2 sites
Sheba Medical Center /ID# 167543
Ramat Gan, 5262100
Tel Aviv Sourasky Medical Ctr /ID# 167542
Tel Aviv, Tel Aviv, 6423906
Sweden2 sites
Centrum for neurologi /ID# 171391
Stockholm, 113 65
Neurologmottagningen /ID# 171390
Stockholm, 171 76
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Advanced Parkinson's Disease, Levodopa-Carbidopa Intestinal Gel (LCIG)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start14 Dec 2017
- Primary completion17 Dec 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362879
- Sponsor's protocol ID
- P16-831
- Acronym
- COSMOS
- Status last verified
- Dec 2019
- First submitted
- 30 Nov 2017
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fasano A, Garcia-Ramos R, Gurevich T, Jech R, Bergmann L, Sanchez-Solino O, Parra JC, Simu M. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: long-term results from COSMOS. J Neurol. 2023 May;270(5):2765-2775. doi: 10.1007/s00415-023-11615-3. Epub 2023 Feb 18.
PubMed 36802031Kovacs 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.
PubMed 36008198
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COSMOS - COmedication Study Assessing Mono- and cOmbination Therapy With Levodopa-carbidopa inteStinal Gel
- ClinicalTrials.gov ID
- NCT03362879
- Acronym / sponsor ID
- COSMOS / P16-831
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Advanced Parkinson's Disease, Levodopa-Carbidopa Intestinal Gel (LCIG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 17 Dec 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months
Time frame: 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 secondary outcomes
Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
Time frame: 12 months
Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation
Time frame: 12 months
Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
Time frame: 12 months
HCRU: Caregiver Support by Number of Participants
Time frame: 12 months
Percentage of Physicians With Overall Preference for LCIG Monotherapy
Time frame: 12 months
Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Time frame: 12 months
Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)
Time frame: 12 months
Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2
Time frame: 12 months
Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country
Time frame: 12 months
Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment
Time frame: 12 months
Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy
Time frame: 12 months
Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36802031Fasano A, Garcia-Ramos R, Gurevich T, Jech R, Bergmann L, Sanchez-Solino O, Parra JC, Simu M. Levodopa-carbidopa intestinal gel in advanced Parkinson's disease: long-term results from COSMOS. J Neurol. 2023 May;270(5):2765-2775. doi: 10.1007/s00415-023-11615-3. Epub 2023 Feb 18.
- Derived from this study: PubMed 36008198Kovacs 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
30 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by AbbVie at 30 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Romania, Canada, Greece, Hungary, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362879, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.