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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

412

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach

11 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

November 30, 2017

Completed

5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed

9 days until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

January 6, 2020

Completed

Last Updated

January 6, 2020

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

November 30, 2017

Results QC Date

December 17, 2019

Last Update Submit

December 17, 2019

Conditions

Parkinson's Disease (PD)

Keywords

Advanced Parkinson's DiseaseLevodopa-Carbidopa Intestinal Gel (LCIG)

Outcome Measures

Primary Outcomes (1)

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 Outcomes (12)

Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation
12 months
Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation
12 months
Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants
12 months
HCRU: Caregiver Support by Number of Participants
12 months
Percentage of Physicians With Overall Preference for LCIG Monotherapy
12 months
+7 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

AbbVielead

Study Sites (30)

Gailtal Klinik /ID# 202505

Hermagor-Pressegger See, Carinthia, 9620, Austria

Location

Medizinische Universität Graz /ID# 202559

Graz, Styria, 8010, Austria

Location

University of Calgary /ID# 206550

Calgary, Alberta, T2N 4Z6, Canada

Location

Ottawa Hospital /ID# 169448

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto Western Hospital /ID# 169038

Toronto, Ontario, M5T 2S8, Canada

Location

Clinique Neuro Levis /ID# 206549

Lévis, Quebec, G6W 0M5, Canada

Location

Clinical Hosp Center Zagreb /ID# 203553

Zagreb, 10000, Croatia

Location

Fakultni nemocnice u sv. Anny v Brne /ID# 209774

Brno, Brno-mesto, 602 00, Czechia

Location

Fakultni Nemocnice Olomouc /ID# 209776

Olomouc, Olomoucký kraj, 779 00, Czechia

Location

Vseobecna Fakultni Nemocnice /ID# 209775

Prague, 128 08, Czechia

Location

Aiginiteio University Hospital /ID# 203476

Athens, Attica, 11528, Greece

Location

HYGEIA Hospital /ID# 203474

Athens, 15123, Greece

Location

Mediterraneo Hospital /ID# 203472

Glyfada, 16675, Greece

Location

University Hospital of Ioannin /ID# 203471

Ioannina, 45500, Greece

Location

Pecsi Tudomanyegyetem /ID# 170026

Pécs, Pecs, 7624, Hungary

Location

Semmelweis Egyetem /ID# 170025

Budapest, 1083, Hungary

Location

Borsod-Abauj-Zemplen Megyei /ID# 170027

Miskolc, 3526, Hungary

Location

Szegedi Tudomanyegyetem /ID# 170028

Szeged, 6720, Hungary

Location

Bon Secours Hospital /ID# 168424

Cork, T12 DV56, Ireland

Location

University Hospital Galway /ID# 170754

Galway, H91 YR71, Ireland

Location

Tel Aviv Sourasky Medical Ctr /ID# 167542

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Sheba Medical Center /ID# 167543

Ramat Gan, 5262100, Israel

Location

Clinic Fundeni Institute /ID# 169265

Bucharest, București, 022328, Romania

Location

Colentina Clinical Hospital /ID# 169263

Bucharest, 20125, Romania

Location

Emergency Clinical County Hosp /ID# 169269

Târgu Mureş, 540042, Romania

Location

Timisoara County /ID# 169266

Timișoara, 300736, Romania

Location

Timisoara County /ID# 169268

Timișoara, 300736, Romania

Location

AbbVie Farmaceutica SLU /ID# 164364

Madrid, Spain

Location

Centrum for neurologi /ID# 171391

Stockholm, 113 65, Sweden

Location

Neurologmottagningen /ID# 171390

Stockholm, 171 76, Sweden

Location

Related Publications (2)

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.
PMID: 36802031DERIVED
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.
PMID: 36008198DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title: Global Medical Services
Organization: AbbVie

Study Officials

AbbVie Inc.
AbbVie
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 5, 2017

Study Start

December 14, 2017

Primary Completion

December 17, 2018

Study Completion

December 17, 2018

Last Updated

January 6, 2020

Results First Posted

January 6, 2020

Record last verified: 2019-12

Locations

RO(5)CA(4)CZ(3)IE(2)HU(4)CR(1)SE(2)IL(2)AU(2)ES(1)GR(4)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (1)

Participants with advanced Parkinson's disease

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (1)

Participants with advanced Parkinson's disease

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations