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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02611713
Other study ID # P14-494
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2016
Est. completion date December 24, 2020

Study information

Verified date December 2021
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date December 24, 2020
Est. primary completion date December 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Kingston Centre /ID# 144374 Cheltenham Victoria
Australia Monash Medical Centre /ID# 144375 Clayton Victoria
Australia Concord Repatriation & Gen Hos /ID# 144373 Concord New South Wales
Australia St. Vincent's Hospital, Darlinghurst /ID# 144376 Darlinghurst New South Wales
Belgium UZ Antwerp /ID# 144378 Edegem
Belgium AZ Groeninge /ID# 144377 Kortrijk
Belgium CHU Tivoli /ID# 144379 La Louviere
Hungary Semmelweis Egyetem /ID# 144381 Budapest
Hungary Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 144380 Pecs
Israel Assaf Harofeh Medical Center /ID# 144383 Be'er Ya'akov
Israel The Edith Wolfson Medical Center /ID# 144382 Holon
Israel Sheba Medical Center /ID# 147099 Ramat Gan
Israel Tel Aviv Sourasky Medical Center /ID# 153779 Tel Aviv-Yafo Tel-Aviv
Italy Ospedale Santo Stefano /ID# 144386 Prato
Italy Azienda Ospedaliera Sant' Andrea /ID# 144385 Rome
Italy A.O. Circolo e Fondazione Macc /ID# 144384 Varese
Romania Spitatlul Clinic Colentina /ID# 144447 Bucharest
Romania Spital Universitar Bucuresti /ID# 144446 Bucharesti
Romania Spitalul Clinic Judetean de Ur /ID# 144451 Oradea, Judet Bihor
Romania Institutul Clinic Fundeni /ID# 144448 Sector 2 Bucuresti
Romania Spitalul Clinic Judetean /ID# 144453 Targu Mures
Romania Sp. Clinic de Judetean /ID# 144449 Timisoara
Romania Sp. Clinic de Judetean /ID# 144452 Timisoara
Slovenia Univ Medical Ctr Ljubljana /ID# 144387 Ljubljana
Spain OSI Ezkerraldea-Enkarterri-Cruces /ID# 151781 Barakaldo
Spain Hospital Universitario Vall d'Hebron /ID# 151778 Barcelona
Spain Hospital Universitario de Burgos /ID# 144406 Burgos
Spain Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 151782 Ferrol A Coruna
Spain CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 162277 Pamplona Navarra, Comunidad
Spain Hospital Universitario Mutua Terrassa /ID# 144405 Terrasa Barcelona
Spain Hospital de Tortosa Verge de la Cinta /ID# 153502 Tortosa Tarragona
United Kingdom King's College Hospital NHS /ID# 147130 London
United Kingdom St. George's Healthcare NHS /ID# 147131 London
United Kingdom Queens Hospital /ID# 147133 Romford
United Kingdom Salford Royal NHS Found Trust /ID# 151783 Salford
United States Georgia Regents University /ID# 144417 Augusta Georgia
United States Johns Hopkins University /ID# 144416 Baltimore Maryland
United States University of Alabama at Birmingham - Main /ID# 144422 Birmingham Alabama
United States Parkinson's Disease and Moveme /ID# 144413 Boca Raton Florida
United States University of Vermont Medical Center /ID# 144410 Burlington Vermont
United States University of Florida - Archer /ID# 144415 Gainesville Florida
United States Mercy St. Mary's Health Center /ID# 144418 Grand Rapids Michigan
United States Penn State Child Hosp.Hersh,PA /ID# 160671 Hershey Pennsylvania
United States University of Kansas Health Sy /ID# 154242 Kansas City Kansas
United States King County Public Hospital /ID# 144412 Kirkland Washington
United States University of Kentucky Chandler Medical Center /ID# 144421 Lexington Kentucky
United States University of Miami /ID# 144420 Miami Florida
United States Vanderbilt Univ Med Ctr /ID# 150782 Nashville Tennessee
United States Univ Nebraska Med Ctr /ID# 147655 Omaha Nebraska
United States University of Pennsylvania /ID# 161135 Philadelphia Pennsylvania
United States Washington University-School of Medicine /ID# 147235 Saint Louis Missouri
United States Northwest Neurological, PLLC /ID# 144409 Spokane Washington
United States Jared Neuroscience Center /ID# 161629 Springfield Missouri
United States Wake Forest Univ HS /ID# 144419 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Hungary,  Israel,  Italy,  Romania,  Slovenia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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. Baseline visit (Enrollment) to month 36
Secondary 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 Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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). Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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. Baseline visit (Enrollment) to month 36
Secondary 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). Baseline visit (Enrollment) to month 36
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary Motor symptoms in Arm B Motor symptoms measured by UPDRS III in ON state and correlation with PKG-based bradykinesia score will be evaluated Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
Secondary 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 Baseline visit (Enrollment) to month 6
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Recruiting NCT06195124 - A Study on the Safety and Tolerability of RGL-193 in Patients With Advanced Parkinson's Disease Early Phase 1
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