Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02611713




Registration number
NCT02611713
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015
Date last updated
6/05/2019

Titles & IDs
Public title
Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
Scientific title
DUOdopa/Duopa in Patients With Advanced Parkinson's Disease (PD) - a GLobal Observational Study Evaluating Long-Term Effectiveness (DUOGLOBE)
Secondary ID [1] 0 0
P14-494
Universal Trial Number (UTN)
Trial acronym
DUOGLOBE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline visit (Enrollment) to month 36
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline visit (Enrollment) to month 6
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline visit (Enrollment) to month 6
Primary outcome [4] 0 0
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))
Timepoint [4] 0 0
Baseline visit (Enrollment) to month 6
Primary outcome [5] 0 0
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)
Timepoint [5] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [12] 0 0
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).
Timepoint [12] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [16] 0 0
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).
Timepoint [16] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [22] 0 0
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
Timepoint [22] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [24] 0 0
Motor symptoms in Arm B - Motor symptoms measured by UPDRS III in ON state and correlation with PKG-based bradykinesia score will be evaluated
Timepoint [24] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [27] 0 0
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
Timepoint [27] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [28] 0 0
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
Timepoint [28] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [29] 0 0
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
Timepoint [29] 0 0
Baseline visit (Enrollment) to month 6

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/03/2021
Actual
Sample size
Target
243
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation & Gen Hos /ID# 144373 - Concord
Recruitment hospital [2] 0 0
St. Vincent's Hospital, Darlinghurst /ID# 144376 - Darlinghurst
Recruitment hospital [3] 0 0
Kingston Centre /ID# 144374 - Cheltenham
Recruitment hospital [4] 0 0
Monash Medical Centre /ID# 144375 - Clayton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3192 - Cheltenham
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Vermont
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Kortrijk
Country [17] 0 0
Belgium
State/province [17] 0 0
La Louviere
Country [18] 0 0
Hungary
State/province [18] 0 0
Pecs
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
Country [20] 0 0
Israel
State/province [20] 0 0
Tel-Aviv
Country [21] 0 0
Israel
State/province [21] 0 0
Be'er Ya'akov
Country [22] 0 0
Israel
State/province [22] 0 0
Holon
Country [23] 0 0
Israel
State/province [23] 0 0
Ramat Gan
Country [24] 0 0
Italy
State/province [24] 0 0
Prato
Country [25] 0 0
Italy
State/province [25] 0 0
Rome
Country [26] 0 0
Italy
State/province [26] 0 0
Varese
Country [27] 0 0
Romania
State/province [27] 0 0
Bucuresti
Country [28] 0 0
Romania
State/province [28] 0 0
Bucharesti
Country [29] 0 0
Romania
State/province [29] 0 0
Bucharest
Country [30] 0 0
Romania
State/province [30] 0 0
Oradea, Judet Bihor
Country [31] 0 0
Romania
State/province [31] 0 0
Targu Mures
Country [32] 0 0
Romania
State/province [32] 0 0
Timisoara
Country [33] 0 0
Slovenia
State/province [33] 0 0
Ljubljana
Country [34] 0 0
Spain
State/province [34] 0 0
Navarra, Comunidad
Country [35] 0 0
Spain
State/province [35] 0 0
Barakaldo
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Burgos
Country [38] 0 0
Spain
State/province [38] 0 0
Ferrol
Country [39] 0 0
Spain
State/province [39] 0 0
Terrasa
Country [40] 0 0
Spain
State/province [40] 0 0
Tortosa
Country [41] 0 0
United Kingdom
State/province [41] 0 0
London
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Romford
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02611713
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Debra Cardoni
Address 0 0
Country 0 0
Phone 0 0
+18479389182
Fax 0 0
Email 0 0
debbie.cardoni@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02611713