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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02611713
Ethics application status
Date submitted
19/11/2015
Date registered
23/11/2015

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
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
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
Timepoint [3] 0 0
Baseline visit (Enrollment) to month 6
Primary outcome [4] 0 0
Duration of bradykinesia score above target in Arm B
Timepoint [4] 0 0
Baseline visit (Enrollment) to month 6
Primary outcome [5] 0 0
Average bradykinesia score in Arm B
Timepoint [5] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [1] 0 0
Change in Disease-Specific Caregiver Burden in Arm A
Timepoint [1] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [2] 0 0
Change in the Duration of Dyskinesia in Arm A
Timepoint [2] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [3] 0 0
Change in Disease-Specific Sleep Quality in Arm A
Timepoint [3] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [4] 0 0
Change in Tremor Severity in Arm A
Timepoint [4] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [5] 0 0
Change in Motor Function in Arm A
Timepoint [5] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [6] 0 0
Change in Generic Quality of Life in Arm A
Timepoint [6] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [7] 0 0
Change in Dyskinesia Severity in Arm A
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
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
Timepoint [9] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [10] 0 0
Change in OFF Time Duration in Arm A
Timepoint [10] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [11] 0 0
Change in Non-Motor Symptoms in Arm A
Timepoint [11] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [12] 0 0
Change in Healthcare Resource Utilization in Arm A
Timepoint [12] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [13] 0 0
Change in Daytime Sleepiness in Arm A
Timepoint [13] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [14] 0 0
Change in Activities of Daily Living in Arm A
Timepoint [14] 0 0
Baseline visit (Enrollment) to month 36
Secondary outcome [15] 0 0
Change in Complications of Therapy in Arm A
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
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
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
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
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
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
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
Timepoint [22] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [23] 0 0
Severity of dyskinesia in Arm B
Timepoint [23] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [24] 0 0
Motor symptoms in Arm B
Timepoint [24] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [25] 0 0
Severity of tremor in Arm B
Timepoint [25] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [26] 0 0
Activities of Daily Living (ADL) in Arm B
Timepoint [26] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [27] 0 0
Sleep in Arm B
Timepoint [27] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [28] 0 0
Daytime sleepiness in Arm B
Timepoint [28] 0 0
Baseline visit (Enrollment) to month 6
Secondary outcome [29] 0 0
Quality of Life (QoL) in Arm B
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
Sex
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
Completed
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
Actual
24/12/2020
Sample size
Target
Accrual to date
Final
213
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
Budapest
Country [19] 0 0
Hungary
State/province [19] 0 0
Pecs
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
A Coruna
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Navarra, Comunidad
Country [37] 0 0
Spain
State/province [37] 0 0
Tarragona
Country [38] 0 0
Spain
State/province [38] 0 0
Barakaldo
Country [39] 0 0
Spain
State/province [39] 0 0
Burgos
Country [40] 0 0
United Kingdom
State/province [40] 0 0
London
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Romford
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Salford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02611713