Clinical trial NCT02611713: Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
Official title: DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Parkinson's disease

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Participants currently in treatment with continuous apomorphine infusion. In case of a previous treatment with continuous subcutaneous apomorphine infusion, there must be at least 4 weeks between discontinuation of this treatment and inclusion into this study.
* 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

Primary outcomes:
measure: Change in the number of hours spent in OFF time in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Duration of OFF time (hours/day) in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Change in Duration of OFF time (hours/day) in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Duration of bradykinesia score above target in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Average bradykinesia score in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
Secondary outcomes:
measure: Change in Disease-Specific Caregiver Burden in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in the Duration of Dyskinesia in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Disease-Specific Sleep Quality in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Tremor Severity in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Motor Function in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Generic Quality of Life in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Dyskinesia Severity in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Overall Clinical Impression of Disease Severity in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Disease-Specific Quality of Life in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in OFF Time Duration in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Non-Motor Symptoms in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Healthcare Resource Utilization in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Daytime Sleepiness in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Activities of Daily Living in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Change in Complications of Therapy in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Correlation of non-motor and motor improvements with Quality of Life improvements in Arm A
timeFrame: Baseline visit (Enrollment) to month 36
measure: Correlation between duration of OFF time measured by UPDRS IV and duration of bradykinesia score above target in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Correlation between duration of OFF time measured by patient with PD Diary and average bradykinesia score in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Correlation between duration of bradykinesia score above target and average bradykinesia score in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Correlation between duration of OFF time measured by patient with PD Diary and duration of bradykinesia score above target in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Correlation between duration of OFF time measured by UPDRS IV and average bradykinesia score in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Correlation between duration of dyskinesia and Unified Dyskinesia Rating Scale (UDysRS) in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Severity of dyskinesia in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Motor symptoms in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Severity of tremor in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Activities of Daily Living (ADL) in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Sleep in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Daytime sleepiness in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
measure: Quality of Life (QoL) in Arm B
timeFrame: Baseline visit (Enrollment) to month 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 144422
state: Alabama
city: Boca Raton
country: United States
facility: Parkinson's Disease and Moveme /ID# 144413
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 144415
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 144420
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University /ID# 144417
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Health Sy /ID# 154242
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 144421
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 144416
state: Maryland
city: Grand Rapids
country: United States
facility: Mercy St. Mary's Health Center /ID# 144418
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 147235
state: Missouri
city: Springfield
country: United States
facility: Jared Neuroscience Center /ID# 161629
state: Missouri
city: Omaha
country: United States
facility: Univ Nebraska Med Ctr /ID# 147655
state: Nebraska
city: Winston-Salem
country: United States
facility: Wake Forest Univ HS /ID# 144419
state: North Carolina
city: Hershey
country: United States
facility: Penn State Child Hosp.Hersh,PA /ID# 160671
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 161135
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr /ID# 150782
state: Tennessee
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 144410
state: Vermont
city: Kirkland
country: United States
facility: King County Public Hospital /ID# 144412
state: Washington
city: Spokane
country: United States
facility: Northwest Neurological, PLLC /ID# 144409
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation & Gen Hos /ID# 144373
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital, Darlinghurst /ID# 144376
state: New South Wales
city: Cheltenham
country: Australia
facility: Kingston Centre /ID# 144374
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 144375
state: Victoria
city: Edegem
country: Belgium
facility: UZ Antwerp /ID# 144378
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 144377
city: La Louviere
country: Belgium
facility: CHU Tivoli /ID# 144379
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 144381
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 144380
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 153779
state: Tel-Aviv
city: Be'er Ya'akov
country: Israel
facility: Assaf Harofeh Medical Center /ID# 144383
city: Holon
country: Israel
facility: The Edith Wolfson Medical Center /ID# 144382
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 147099
city: Prato
country: Italy
facility: Ospedale Santo Stefano /ID# 144386
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant' Andrea /ID# 144385
city: Varese
country: Italy
facility: A.O. Circolo e Fondazione Macc /ID# 144384
city: Sector 2
country: Romania
facility: Institutul Clinic Fundeni /ID# 144448
state: Bucuresti
city: Bucharesti
country: Romania
facility: Spital Universitar Bucuresti /ID# 144446
city: Bucharest
country: Romania
facility: Spitatlul Clinic Colentina /ID# 144447
city: Oradea, Judet Bihor
country: Romania
facility: Spitalul Clinic Judetean de Ur /ID# 144451
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean /ID# 144453
city: Timisoara
country: Romania
facility: Sp. Clinic de Judetean /ID# 144449
city: Timisoara
country: Romania
facility: Sp. Clinic de Judetean /ID# 144452
city: Ljubljana
country: Slovenia
facility: Univ Medical Ctr Ljubljana /ID# 144387
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 151782
state: A Coruna
city: Terrasa
country: Spain
facility: Hospital Universitario Mutua Terrassa /ID# 144405
state: Barcelona
city: Pamplona
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 162277
state: Navarra, Comunidad
city: Tortosa
country: Spain
facility: Hospital de Tortosa Verge de la Cinta /ID# 153502
state: Tarragona
city: Barakaldo
country: Spain
facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 151781
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 151778
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos /ID# 144406
city: London
country: United Kingdom
facility: King's College Hospital NHS /ID# 147130
city: London
country: United Kingdom
facility: St. George's Healthcare NHS /ID# 147131
city: Romford
country: United Kingdom
facility: Queens Hospital /ID# 147133
city: Salford
country: United Kingdom
facility: Salford Royal NHS Found Trust /ID# 151783
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.