Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease

NCT02611713 | Completed

• 1 other identifier: P14-494
• Study Type: observational
• Target: 213
• Locations: 10 countries
• Sites: 54

Brief Summary

This study is a non-interventional post-marketing observational study (PMOS) of participants with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical setting. Effectiveness of treatment will be collected with physician and participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6 months thereafter up to 36 months. An additional cohort of participants will be enrolled who in addition will be evaluated with a wearable device.

Conditions

Advanced Parkinson's Disease

Keywords

Advanced Parkinson's Disease; Duodopa/Duopa; carbidopa levodopa enteral suspension (CLES); levodopa-carbidopa intestinal gel (LCIG); OFF time; motor and non-motor symptoms; dyskinesia; tremor; Quality of Life; Observational; Long-term; Caregiver Burden; effectiveness; fluctuations

Outcome Measures

Primary Outcomes (5)

• Change in the number of hours spent in OFF time in Arm A

  Assess the effectiveness of Duodopa/Duopa treatment on OFF time measured by the change (from baseline to 36 months) in the number of hours spent in OFF time as reported by the participant for the day prior to the clinical visit.

  Baseline visit (Enrollment) to month 36

• Change in Duration of OFF time (hours/day) in Arm B

  Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in OFF time duration as measured by UPDRS Part IV (Motor Symptoms), item 39.

  Baseline visit (Enrollment) to month 6

• Change in Duration of OFF time (hours/day) in Arm B

  Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in OFF time duration as reported by participant with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00

  Baseline visit (Enrollment) to month 6

• Duration of bradykinesia score above target in Arm B

  Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day (measured by Parkinson's KinetiGraph ( PKG))

  Baseline visit (Enrollment) to month 6

• Average bradykinesia score in Arm B

  Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 6 months) in average bradykinesia score (measured by PKG)

  Baseline visit (Enrollment) to month 6

Secondary Outcomes (29)

• Change in Disease-Specific Caregiver Burden in Arm A

  Baseline visit (Enrollment) to month 36

• Change in the Duration of Dyskinesia in Arm A

  Baseline visit (Enrollment) to month 36

• Change in Disease-Specific Sleep Quality in Arm A

  Baseline visit (Enrollment) to month 36

• Change in Tremor Severity in Arm A

  Baseline visit (Enrollment) to month 36

• Change in Motor Function in Arm A

  Baseline visit (Enrollment) to month 36

Study Arms (2)

Arm A: Participants with Advanced Parkinson's Disease

Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries.

Arm B: Participants with Advanced Parkinson's Disease

Participants who along with their physicians have elected for treatment with Duodopa/Duopa and are prescribed according to the local product label and reimbursement guidelines for their participating countries. Participants will be evaluated with a wearable device

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced Parkinson's disease

You may qualify if:

• Eligibility for Duodopa/Duopa therapy in accordance with the approved local Duodopa/Duopa label in the participating country.
• Duodopa/Duopa naïve participants
• Decision to treat with Duodopa/Duopa made by the physician prior to any decision to approach the participant to participate in this study
• Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the subject has had the opportunity to have questions answered.
• For Arm B: Participant and caregiver must be motivated to use the PKG, understand the instructions and be able to handle the device.
• For Arm B: participant must demonstrate at least 75% concordance with the investigator's or qualified designee's assessment of symptoms on the Parkinson's disease diary following training at enrollment visit 1/V1 with concordance on at least 1 time interval of "Off", concordance on at least 1 time interval of "ON regardless of dyskinesia" and at least 1 time interval of "ON with dyskinesia" irrespective of whether the dyskinesia are troublesome or not troublesome.

You may not qualify if:

• Any condition included in the contraindications section of the approved local Duodopa/Duopa label in the participating country.
• Participants who have had previous surgery for PD including, but not limited to deep brain stimulation (DBS) or cell transplantation (this criterion removed for US sites for Arm A).
• Mini-Mental State Examination (MMSE) score \<24
• Participation in a concurrent interventional clinical trial.
• Lack of motivation or insufficient language skills to complete the study questionnaires

Sponsors & Collaborators

• AbbVie: lead

Study Sites (54)

University of Alabama at Birmingham - Main /ID# 144422

Birmingham, Alabama, 35233, United States

Location

Parkinson's Disease and Moveme /ID# 144413

Boca Raton, Florida, 33486, United States

Location

University of Florida - Archer /ID# 144415

Gainesville, Florida, 32610, United States

Location

University of Miami /ID# 144420

Miami, Florida, 33138, United States

Location

Georgia Regents University /ID# 144417

Augusta, Georgia, 30912, United States

Location

University of Kansas Health Sy /ID# 154242

Kansas City, Kansas, 66160-8500, United States

Location

University of Kentucky Chandler Medical Center /ID# 144421

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins University /ID# 144416

Baltimore, Maryland, 21287, United States

Location

Mercy St. Mary's Health Center /ID# 144418

Grand Rapids, Michigan, 49503, United States

Location

Jared Neuroscience Center /ID# 161629

Springfield, Missouri, 65804, United States

Location

Washington University-School of Medicine /ID# 147235

St Louis, Missouri, 63110, United States

Location

Univ Nebraska Med Ctr /ID# 147655

Omaha, Nebraska, 68198, United States

Location

Wake Forest Univ HS /ID# 144419

Winston-Salem, North Carolina, 27157, United States

Location

Penn State Child Hosp.Hersh,PA /ID# 160671

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania /ID# 161135

Philadelphia, Pennsylvania, 19104-5502, United States

Location

Vanderbilt Univ Med Ctr /ID# 150782

Nashville, Tennessee, 37232-0011, United States

Location

University of Vermont Medical Center /ID# 144410

Burlington, Vermont, 05401-1473, United States

Location

King County Public Hospital /ID# 144412

Kirkland, Washington, 98034, United States

Location

Northwest Neurological, PLLC /ID# 144409

Spokane, Washington, 99202, United States

Location

Concord Repatriation & Gen Hos /ID# 144373

Concord, New South Wales, 2139, Australia

Location

St. Vincent's Hospital, Darlinghurst /ID# 144376

Darlinghurst, New South Wales, 2010, Australia

Location

Kingston Centre /ID# 144374

Cheltenham, Victoria, 3192, Australia

Location

Monash Medical Centre /ID# 144375

Clayton, Victoria, 3168, Australia

Location

UZ Antwerp /ID# 144378

Edegem, 2650, Belgium

Location

AZ Groeninge /ID# 144377

Kortrijk, 8500, Belgium

Location

CHU Tivoli /ID# 144379

La Louvière, 7100, Belgium

Location

Semmelweis Egyetem /ID# 144381

Budapest, 1085, Hungary

Location

Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 144380

Pécs, 7624, Hungary

Location

Tel Aviv Sourasky Medical Center /ID# 153779

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Assaf Harofeh Medical Center /ID# 144383

Be’er Ya‘aqov, 70300, Israel

Location

The Edith Wolfson Medical Center /ID# 144382

Holon, 58100, Israel

Location

Sheba Medical Center /ID# 147099

Ramat Gan, 5239424, Israel

Location

Ospedale Santo Stefano /ID# 144386

Prato, 59100, Italy

Location

Azienda Ospedaliera Sant' Andrea /ID# 144385

Rome, 00189, Italy

Location

A.O. Circolo e Fondazione Macc /ID# 144384

Varese, 21100, Italy

Location

Institutul Clinic Fundeni /ID# 144448

Sector 2, București, 022328, Romania

Location

Spitatlul Clinic Colentina /ID# 144447

Bucharest, 020125, Romania

Location

Spital Universitar Bucuresti /ID# 144446

Bucharesti, 050098, Romania

Location

Spitalul Clinic Judetean de Ur /ID# 144451

Oradea, Judet Bihor, 410028, Romania

Location

Spitalul Clinic Judetean /ID# 144453

Târgu Mureş, 540136, Romania

Location

Sp. Clinic de Judetean /ID# 144449

Timișoara, 300736, Romania

Location

Sp. Clinic de Judetean /ID# 144452

Timișoara, 300736, Romania

Location

Univ Medical Ctr Ljubljana /ID# 144387

Ljubljana, 1000, Slovenia

Location

Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 151782

Ferrol, A Coruna, 15405, Spain

Location

Hospital Universitario Mutua Terrassa /ID# 144405

Terrassa, Barcelona, 08221, Spain

Location

CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 162277

Pamplona, Navarra, Comunidad, 31008, Spain

Location

Hospital de Tortosa Verge de la Cinta /ID# 153502

Tortosa, Tarragona, 43500, Spain

Location

OSI Ezkerraldea-Enkarterri-Cruces /ID# 151781

Barakaldo, 48903, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 151778

Barcelona, 08035, Spain

Location

Hospital Universitario de Burgos /ID# 144406

Burgos, 09006, Spain

Location

King's College Hospital NHS /ID# 147130

London, SE5 9RS, United Kingdom

Location

St. George's Healthcare NHS /ID# 147131

London, SW17 0QT, United Kingdom

Location

Queens Hospital /ID# 147133

Romford, RM7 0AG, United Kingdom

Location

Salford Royal NHS Found Trust /ID# 151783

Salford, M6 8HD, United Kingdom

Location

Related Publications (2)

• Chaudhuri KR, Kovacs N, Pontieri FE, Aldred J, Bourgeois P, Davis TL, Cubo E, Anca-Herschkovitsch M, Iansek R, Siddiqui MS, Simu M, Bergmann L, Ballina M, Kukreja P, Ladhani O, Jia J, Standaert DG. Levodopa Carbidopa Intestinal Gel in Advanced Parkinson's Disease: DUOGLOBE Final 3-Year Results. J Parkinsons Dis. 2023;13(5):769-783. doi: 10.3233/JPD-225105.

  PMID: 37302039 DERIVED

• Aldred J, Anca-Herschkovitsch M, Antonini A, Bajenaru O, Bergmann L, Bourgeois P, Cubo E, Davis TL, Iansek R, Kovacs N, Kukreja P, Onuk K, Pontieri FE, Robieson W, Siddiqui MS, Simu M, Standaert DG, Chaudhuri KR. Application of the '5-2-1' screening criteria in advanced Parkinson's disease: interim analysis of DUOGLOBE. Neurodegener Dis Manag. 2020 Oct;10(5):309-323. doi: 10.2217/nmt-2020-0021. Epub 2020 Sep 2.

  PMID: 32873195 DERIVED

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Dyskinesias; Tremor; Caregiver Burden

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 23, 2015
• Study Start: January 4, 2016
• Primary Completion: December 24, 2020
• Study Completion: December 24, 2020
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

RO (7); GB (4); US (19); ES (7); AU (4); IL (4); BE (3); HU (2); IT (3); SL (1)