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)
NCT ID: NCT02799381
Last Updated: 2020-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
63 participants
INTERVENTIONAL
2017-02-09
2019-09-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Optimized Medical Treatment (OMT)
Participants 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.
Optimized antiparkinsonian treatment
Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.
Levodopa-Carbidopa Intestinal Gel (LCIG)
The 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.
Levodopa-Carbidopa Intestinal Gel (LCIG)
Dose levels were individually optimized.
CADD-Legacy ambulatory infusion pump
(manufactured by Smiths Medical)
Percutaneous endoscopic gastrostomy tube
(PEG tube)
Jejunal extension tube
(J-tube)
Interventions
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Optimized antiparkinsonian treatment
Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.
Levodopa-Carbidopa Intestinal Gel (LCIG)
Dose levels were individually optimized.
CADD-Legacy ambulatory infusion pump
(manufactured by Smiths Medical)
Percutaneous endoscopic gastrostomy tube
(PEG tube)
Jejunal extension tube
(J-tube)
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
30 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095
Port Charlotte, Florida, United States
Central Texas Neurology Consul /ID# 150088
Round Rock, Texas, United States
Helsinki Univ Central Hospital /ID# 151214
Helsinki, , Finland
Oulun yliopistollinen sairaala /ID# 150947
Oulu, , Finland
Mediterraneo Hospital /ID# 150955
Glyfada, , Greece
University General Hospital of Heraklion "PA.G.N.I" /ID# 150956
Heraklion, , Greece
University Hospital of Ioannin /ID# 150954
Ioannina, , Greece
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116
Pécs, Pecs, Hungary
Semmelweis Egyetem /ID# 170117
Budapest, , Hungary
Szegedi Tudomanyegyetem /ID# 170115
Szeged, , Hungary
Policlinico Universitario Campus Bio-Medico /ID# 150846
Rome, Lazio, Italy
A.O. Univ. Ospedali Riuniti /ID# 150853
Ancona, The Marches, Italy
Azienda USL Toscana Centro /ID# 150770
Florence, , Italy
Seconda Universita' di Napoli /ID# 150851
Naples, , Italy
Policlinico Tor Vergata /ID# 151167
Rome, , Italy
Univerzitna nemocnica L. Pasteura /ID# 150146
Košice - Západ, Košice Region, Slovakia
Univerzitna Nemocnica Bratislava /ID# 150144
Bratislava, , Slovakia
Univerzitna Nemocnica Bratislava /ID# 150171
Bratislava, , Slovakia
Univerzitna nemocnica Martin /ID# 150145
Martin, Žilina Region, Slovakia
Hospital Regional Universitari /ID# 171485
Málaga, Malaga, Spain
Hospital Universitario Cruces /ID# 203807
Barakaldo, , Spain
Hospital General Univ de Elche /ID# 150154
Elche, , Spain
Hospital Univ de la Princesa /ID# 150157
Madrid, , Spain
Hospital General Universitario Gregorio Maranon /ID# 150155
Madrid, , Spain
Hospital Univ Ramon y Cajal /ID# 150152
Madrid, , Spain
Hospital Universitario Infanta /ID# 159696
Madrid, , Spain
Hospital Universitario Virgen Macarena /ID# 158861
Seville, , Spain
Hospital Virgen de la Salud /ID# 166297
Toledo, , Spain
Countries
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References
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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.
Freire-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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2016-001403-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M15-535
Identifier Type: -
Identifier Source: org_study_id
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