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

NCT ID: NCT03362879

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 412 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2018-12-17

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.

Conditions

Parkinson's Disease (PD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Gailtal Klinik /ID# 202505

Hermagor-Pressegger See, Carinthia, Austria

Medizinische Universität Graz /ID# 202559

Graz, Styria, Austria

University of Calgary /ID# 206550

Calgary, Alberta, Canada

Ottawa Hospital /ID# 169448

Ottawa, Ontario, Canada

Toronto Western Hospital /ID# 169038

Toronto, Ontario, Canada

Clinique Neuro Levis /ID# 206549

Lévis, Quebec, Canada

Clinical Hosp Center Zagreb /ID# 203553

Zagreb, , Croatia

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

Brno, Brno-mesto, Czechia

Fakultni Nemocnice Olomouc /ID# 209776

Olomouc, Olomoucký kraj, Czechia

Vseobecna Fakultni Nemocnice /ID# 209775

Prague, , Czechia

Aiginiteio University Hospital /ID# 203476

Athens, Attica, Greece

HYGEIA Hospital /ID# 203474

Athens, , Greece

Mediterraneo Hospital /ID# 203472

Glyfada, , Greece

University Hospital of Ioannin /ID# 203471

Ioannina, , Greece

Pecsi Tudomanyegyetem /ID# 170026

Pécs, Pecs, Hungary

Semmelweis Egyetem /ID# 170025

Budapest, , Hungary

Borsod-Abauj-Zemplen Megyei /ID# 170027

Miskolc, , Hungary

Szegedi Tudomanyegyetem /ID# 170028

Szeged, , Hungary

Bon Secours Hospital /ID# 168424

Cork, , Ireland

University Hospital Galway /ID# 170754

Galway, , Ireland

Tel Aviv Sourasky Medical Ctr /ID# 167542

Tel Aviv, Tel Aviv, Israel

Sheba Medical Center /ID# 167543

Ramat Gan, , Israel

Clinic Fundeni Institute /ID# 169265

Bucharest, București, Romania

Colentina Clinical Hospital /ID# 169263

Bucharest, , Romania

Emergency Clinical County Hosp /ID# 169269

Târgu Mureş, , Romania

Timisoara County /ID# 169266

Timișoara, , Romania

Timisoara County /ID# 169268

Timișoara, , Romania

AbbVie Farmaceutica SLU /ID# 164364

Madrid, , Spain

Centrum for neurologi /ID# 171391

Stockholm, , Sweden

Neurologmottagningen /ID# 171390

Stockholm, , Sweden

Countries

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

References

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.

Reference Type: DERIVED

PMID: 36802031 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36008198 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P16-831

Identifier Type: -

Identifier Source: org_study_id