A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)
DYSCOVER
An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)
2 other identifiers
interventional
63
7 countries
28
Brief Summary
The primary objective of this study was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinson's disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2017
Typical duration for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 14, 2016
CompletedStudy Start
First participant enrolled
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedResults Posted
Study results publicly available
August 18, 2020
CompletedAugust 18, 2020
August 1, 2020
2.6 years
June 10, 2016
August 10, 2020
August 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score
The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement.
Baseline, Week 12
Secondary Outcomes (6)
Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia
Baseline, Week 12
Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index
Baseline, Week 12
Mean Clinical Global Impression of Change (CGI-C) Score at Week 12
Baseline, Week 12
Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living)
Baseline, Week 12
Mean Change From Baseline to Week 12 in OFF Time
Baseline, Week 12
- +1 more secondary outcomes
Study Arms (2)
Optimized Medical Treatment (OMT)
ACTIVE COMPARATORParticipants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
Levodopa-Carbidopa Intestinal Gel (LCIG)
EXPERIMENTALThe total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
Interventions
Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.
Dose levels were individually optimized.
(manufactured by Smiths Medical)
Eligibility Criteria
You may qualify if:
- Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigator's clinical judgment)
- Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3
You may not qualify if:
- Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously
- Participant's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD
- Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
- Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma)
- Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (28)
Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095
Port Charlotte, Florida, 33980, United States
Central Texas Neurology Consul /ID# 150088
Round Rock, Texas, 78681, United States
Helsinki Univ Central Hospital /ID# 151214
Helsinki, 00290, Finland
Oulun yliopistollinen sairaala /ID# 150947
Oulu, 90220, Finland
Mediterraneo Hospital /ID# 150955
Glyfada, 16675, Greece
University General Hospital of Heraklion "PA.G.N.I" /ID# 150956
Heraklion, 71110, Greece
University Hospital of Ioannin /ID# 150954
Ioannina, 45500, Greece
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116
Pécs, Pecs, 7624, Hungary
Semmelweis Egyetem /ID# 170117
Budapest, 1085, Hungary
Szegedi Tudomanyegyetem /ID# 170115
Szeged, 6720, Hungary
Policlinico Universitario Campus Bio-Medico /ID# 150846
Rome, Lazio, 00128, Italy
A.O. Univ. Ospedali Riuniti /ID# 150853
Ancona, The Marches, 60126, Italy
Azienda USL Toscana Centro /ID# 150770
Florence, 50012, Italy
Seconda Universita' di Napoli /ID# 150851
Naples, 80138, Italy
Policlinico Tor Vergata /ID# 151167
Rome, 00133, Italy
Univerzitna nemocnica L. Pasteura /ID# 150146
Košice - Západ, Košice Region, 041 66, Slovakia
Univerzitna Nemocnica Bratislava /ID# 150144
Bratislava, 821 01, Slovakia
Univerzitna Nemocnica Bratislava /ID# 150171
Bratislava, 821 01, Slovakia
Univerzitna nemocnica Martin /ID# 150145
Martin, Žilina Region, 036 01, Slovakia
Hospital Regional Universitari /ID# 171485
Málaga, Malaga, 29010, Spain
Hospital Universitario Cruces /ID# 203807
Barakaldo, 48903, Spain
Hospital General Univ de Elche /ID# 150154
Elche, 03202, Spain
Hospital Univ de la Princesa /ID# 150157
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon /ID# 150155
Madrid, 28007, Spain
Hospital Univ Ramon y Cajal /ID# 150152
Madrid, 28034, Spain
Hospital Universitario Infanta /ID# 159696
Madrid, 28702, Spain
Hospital Universitario Virgen Macarena /ID# 158861
Seville, 41009, Spain
Hospital Virgen de la Salud /ID# 166297
Toledo, 45005, Spain
Related Publications (2)
Freire-Alvarez E, Vanni P, Kurca E, Lopez-Manzanares L, Kovacs N, Spanaki C, Gao T, Bergmann L, Sanchez-Solino O. Dyskinesia and Pain in Advanced Parkinson's Disease: Post Hoc Analysis from the Phase 3b, Open-Label, Randomized DYSCOVER Study. Neurol Ther. 2024 Apr;13(2):437-447. doi: 10.1007/s40120-024-00583-z. Epub 2024 Feb 12.
PMID: 38345741DERIVEDFreire-Alvarez E, Kurca E, Lopez Manzanares L, Pekkonen E, Spanaki C, Vanni P, Liu Y, Sanchez-Solino O, Barbato LM. Levodopa-Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial. Mov Disord. 2021 Nov;36(11):2615-2623. doi: 10.1002/mds.28703. Epub 2021 Jul 8.
PMID: 34236101DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 14, 2016
Study Start
February 9, 2017
Primary Completion
September 19, 2019
Study Completion
September 19, 2019
Last Updated
August 18, 2020
Results First Posted
August 18, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.