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Advanced Parkinson's DiseaseDUOGLOBENCT02611713

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

An observational study of Advanced Parkinson's Disease, run by AbbVie at 54 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Parkinson's Disease
How many people
213 participants
Where
54 sitesin 10 countries
Study dates
4 Jan 2016to 24 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Advanced Parkinson's disease

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

54 sites in 10 countries.

54 sites in 10 countries

United States19 sites

  • Georgia Regents University /ID# 144417

    Augusta, Georgia, 30912

  • Johns Hopkins University /ID# 144416

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham - Main /ID# 144422

    Birmingham, Alabama, 35233

  • Parkinson's Disease and Moveme /ID# 144413

    Boca Raton, Florida, 33486

  • University of Vermont Medical Center /ID# 144410

    Burlington, Vermont, 05401-1473

  • University of Florida - Archer /ID# 144415

    Gainesville, Florida, 32610

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

    Grand Rapids, Michigan, 49503

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

    Hershey, Pennsylvania, 17033

  • University of Kansas Health Sy /ID# 154242

    Kansas City, Kansas, 66160-8500

  • King County Public Hospital /ID# 144412

    Kirkland, Washington, 98034

  • University of Kentucky Chandler Medical Center /ID# 144421

    Lexington, Kentucky, 40536

  • University of Miami /ID# 144420

    Miami, Florida, 33138

  • Vanderbilt Univ Med Ctr /ID# 150782

    Nashville, Tennessee, 37232-0011

  • Univ Nebraska Med Ctr /ID# 147655

    Omaha, Nebraska, 68198

  • University of Pennsylvania /ID# 161135

    Philadelphia, Pennsylvania, 19104-5502

  • Northwest Neurological, PLLC /ID# 144409

    Spokane, Washington, 99202

  • Jared Neuroscience Center /ID# 161629

    Springfield, Missouri, 65804

  • Washington University-School of Medicine /ID# 147235

    St Louis, Missouri, 63110

  • Wake Forest Univ HS /ID# 144419

    Winston-Salem, North Carolina, 27157

Other trials in United States

Romania7 sites

  • Spitatlul Clinic Colentina /ID# 144447

    Bucharest, 020125

  • Spital Universitar Bucuresti /ID# 144446

    Bucharesti, 050098

  • Spitalul Clinic Judetean de Ur /ID# 144451

    Oradea, Judet Bihor, 410028

  • Institutul Clinic Fundeni /ID# 144448

    Sector 2, Bucharest, 022328

  • Spitalul Clinic Judetean /ID# 144453

    Târgu Mureş, 540136

  • Sp. Clinic de Judetean /ID# 144449

    Timișoara, 300736

  • Sp. Clinic de Judetean /ID# 144452

    Timișoara, 300736

Other trials in Romania

Spain7 sites

  • OSI Ezkerraldea-Enkarterri-Cruces /ID# 151781

    Barakaldo, 48903

  • Hospital Universitario Vall d'Hebron /ID# 151778

    Barcelona, 08035

  • Hospital Universitario de Burgos /ID# 144406

    Burgos, 09006

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

    Ferrol, A Coruna, 15405

  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 162277

    Pamplona, Navarra, Comunidad, 31008

  • Hospital Universitario Mutua Terrassa /ID# 144405

    Terrassa, Barcelona, 08221

  • Hospital de Tortosa Verge de la Cinta /ID# 153502

    Tortosa, Tarragona, 43500

Other trials in Spain

Australia4 sites

  • Kingston Centre /ID# 144374

    Cheltenham, Victoria, 3192

  • Monash Medical Centre /ID# 144375

    Clayton, Victoria, 3168

  • Concord Repatriation & Gen Hos /ID# 144373

    Concord, New South Wales, 2139

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

    Darlinghurst, New South Wales, 2010

Other trials in Australia

Israel4 sites

  • Assaf Harofeh Medical Center /ID# 144383

    Be’er Ya‘aqov, 70300

  • The Edith Wolfson Medical Center /ID# 144382

    Holon, 58100

  • Sheba Medical Center /ID# 147099

    Ramat Gan, 5239424

  • Tel Aviv Sourasky Medical Center /ID# 153779

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

United Kingdom4 sites

  • King's College Hospital NHS /ID# 147130

    London, SE5 9RS

  • St. George's Healthcare NHS /ID# 147131

    London, SW17 0QT

  • Queens Hospital /ID# 147133

    Romford, RM7 0AG

  • Salford Royal NHS Found Trust /ID# 151783

    Salford, M6 8HD

Other trials in United Kingdom

Belgium3 sites

  • UZ Antwerp /ID# 144378

    Edegem, 2650

  • AZ Groeninge /ID# 144377

    Kortrijk, 8500

  • CHU Tivoli /ID# 144379

    La Louvière, 7100

Other trials in Belgium

Italy3 sites

  • Ospedale Santo Stefano /ID# 144386

    Prato, 59100

  • Azienda Ospedaliera Sant' Andrea /ID# 144385

    Rome, 00189

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

    Varese, 21100

Other trials in Italy

Hungary2 sites

  • Semmelweis Egyetem /ID# 144381

    Budapest, 1085

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

    Pécs, 7624

Other trials in Hungary

Slovenia1 site

  • Univ Medical Ctr Ljubljana /ID# 144387

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)

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.

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
Medical subject headings
Dyskinesias, Tremor, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02611713
Study groupRoleWhat they receive
Arm A: Participants with Advanced Parkinson's DiseaseParticipants 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 DiseaseParticipants 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline visit (Enrollment) to month 36

  2. 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.

    Measured: Baseline visit (Enrollment) to month 6

  3. 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

    Measured: Baseline visit (Enrollment) to month 6

  4. 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))

    Measured: Baseline visit (Enrollment) to month 6

  5. 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)

    Measured: Baseline visit (Enrollment) to month 6

Secondary outcomes (29)

  1. Change in Disease-Specific Caregiver Burden in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific caregiver burden as measured by the Modified Caregiver Strain Index (MCSI) for PD with a total score range from 0 to 26.

    Measured: Baseline visit (Enrollment) to month 36

  2. Change in the Duration of Dyskinesia in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in duration of dyskinesia as reported by the patient for the day prior to the clinical visit

    Measured: Baseline visit (Enrollment) to month 36

  3. Change in Disease-Specific Sleep Quality in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific sleep quality as measured by Parkinson's Disease Sleep Scale-2 (PDSS-2) with a total score range from 0 to 60.

    Measured: Baseline visit (Enrollment) to month 36

  4. Change in Tremor Severity in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in tremor severity as measured by UPDRS Part III, item 20 (Tremor at Rest) with a total score range of 0 to 20.

    Measured: Baseline visit (Enrollment) to month 36

  5. Change in Motor Function in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in motor function as measured by UPDRS, Part III (Motor Examination) with a total score range of 0 to 108.

    Measured: Baseline visit (Enrollment) to month 36

  6. Change in Generic Quality of Life in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in generic quality of life as measured by EuroQoL-5 Dimensions Quality of Life Questionnaire (EQ-5D). This assessment contains a health state descriptive part with five items scored from 1 to 3.

    Measured: Baseline visit (Enrollment) to month 36

  7. Change in Dyskinesia Severity in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in dyskinesia severity as measured by Unified Dyskinesia Rating Scale (UDysRS) with a total score range from 0 to 104.

    Measured: Baseline visit (Enrollment) to month 36

  8. Change in Overall Clinical Impression of Disease Severity in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in overall clinical impression of disease severity as measured by Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD) obtained by adding four domain scores with a total score range from 0 to 24.

    Measured: Baseline visit (Enrollment) to month 36

  9. Change in Disease-Specific Quality of Life in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in disease-specific quality of life (QoL) as measured by Parkinson's Disease Questionnaire 8 (PDQ-8) summary index range from 0 to 100.

    Measured: Baseline visit (Enrollment) to month 36

  10. Change in OFF Time Duration in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in OFF time duration as measured by UPDRS Part IV (Motor Fluctuations), item 39, with a total score range of 0 to 4.

    Measured: Baseline visit (Enrollment) to month 36

  11. Change in Non-Motor Symptoms in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in non-motor symptoms as measured by Non-Motor Symptoms Scale (NMSS) with a total score range from 0 to 360.

    Measured: Baseline visit (Enrollment) to month 36

  12. Change in Healthcare Resource Utilization in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in healthcare resource utilization as measured by the Healthcare Resource Utilization Questionnaire (HCRU).

    Measured: Baseline visit (Enrollment) to month 36

  13. Change in Daytime Sleepiness in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in daytime sleepiness as measured by Epworth Sleepiness Scale (ESS) with a total score range from 0 to 24.

    Measured: Baseline visit (Enrollment) to month 36

  14. Change in Activities of Daily Living in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in Activities of Daily Living as measured by Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activity of Daily Living) with a total score range of 0 to 52.

    Measured: Baseline visit (Enrollment) to month 36

  15. Change in Complications of Therapy in Arm A

    Assess the effectiveness of Duodopa/Duopa treatment measured by the change (from baseline to 36 months) in Complications of Therapy (dyskinesia duration, disability, pain and early morning dystonia) as measured by UPDRS Part IV (Complications of Therapy), items 32 (individual score 0 to 4), 33 (individual score 0 to 4), 34 (individual score 0 to 4), 35 (individual score 0 to 1) and total score range of 0 to 13.

    Measured: Baseline visit (Enrollment) to month 36

  16. Correlation of non-motor and motor improvements with Quality of Life improvements in Arm A

    Assess the correlation of non-motor and motor improvements with the improvement in the Quality of Life (QOL).

    Measured: Baseline visit (Enrollment) to month 36

  17. Correlation between duration of OFF time measured by UPDRS IV and duration of bradykinesia score above target in Arm B

    Assess the correlation between duration of OFF time measured by UPDRS IV item 39 and duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day measured by PKG

    Measured: Baseline visit (Enrollment) to month 6

  18. Correlation between duration of OFF time measured by patient with PD Diary and average bradykinesia score in Arm B

    Assess the correlation between duration of OFF time measured by patient with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00 and average bradykinesia score measured by PKG

    Measured: Baseline visit (Enrollment) to month 6

  19. Correlation between duration of bradykinesia score above target and average bradykinesia score in Arm B

    Assess the correlation between duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day measured by PKG and average bradykinesia score measured by PKG

    Measured: Baseline visit (Enrollment) to month 6

  20. Correlation between duration of OFF time measured by patient with PD Diary and duration of bradykinesia score above target in Arm B

    Assess the correlation between duration of OFF time measured by patient with PD Diary both per full 24 hours and for the time period of 09:00 - 18:00 and duration of bradykinesia score above target between 09:00 - 18:00 and for the full 24 hours per day measured by PKG

    Measured: Baseline visit (Enrollment) to month 6

  21. Correlation between duration of OFF time measured by UPDRS IV and average bradykinesia score in Arm B

    Assess the correlation between duration of OFF time measured by UPDRS IV item 39 and average bradykinesia score measured by PKG

    Measured: Baseline visit (Enrollment) to month 6

  22. Correlation between duration of dyskinesia and Unified Dyskinesia Rating Scale (UDysRS) in Arm B

    Pairwise correlation between duration of dyskinesia both per full 24 hours and 09:00 - 18:00 (based on UPDRS IV, PD diary and dyskinesia score measured by PKG) and UDysRS will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  23. Severity of dyskinesia in Arm B

    Severity of dyskinesia (item 33 score of UPDRS IV, UDysRS total score or the PKG-based dyskinesia score and the pairwise correlation between these will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  24. Motor symptoms in Arm B

    Motor symptoms measured by UPDRS III in ON state and correlation with PKG-based bradykinesia score will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  25. Severity of tremor in Arm B

    Severity of tremor measured by item 20 of UPDRS III in ON state and PKG-based tremor score and correlation between both will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  26. Activities of Daily Living (ADL) in Arm B

    ADL measured by UPDRS II in ON state and correlation with and PKG-based fluctuation/dyskinesia score and bradykinesia score will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  27. Sleep in Arm B

    Sleep as measured by PDSS-2, sleep/fatigue subdomain of NMSS, duration of sleep based on PD Diary or PKG-based night-time total sleep and pairwise correlation between these will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  28. Daytime sleepiness in Arm B

    Daytime sleepiness as measured by PKG-based percent of time asleep in the day time and the Epworth Sleepiness Scale and the correlation between these will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

  29. Quality of Life (QoL) in Arm B

    QoL as measured by PDQ-8 and the correlation with PKG-based fluctuation/dyskinesia and bradykinesia scores will be evaluated

    Measured: Baseline visit (Enrollment) to month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2015 (estimated)
  2. Study start4 Jan 2016
  3. Primary completion24 Dec 2020
  4. Study completion24 Dec 2020

Resources

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
Prospective
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02611713
Sponsor's protocol ID
P14-494
Acronym
DUOGLOBE
Status last verified
Dec 2021
First submitted
19 Nov 2015
Last updated
15 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37302039

  • 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.

    PubMed 32873195

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Parkinson's Disease, run by AbbVie at 54 sites in 10 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 6 inclusion and 6 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Romania, Spain, Australia, Israel and 5 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in the number of hours spent in OFF time in Arm A (time frame: Baseline visit (Enrollment) to month 36). The study lists 5 primary outcomes in all. 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 NCT02611713, 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 15 Dec 2021.

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