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)
Completed · Phase 3
Conditions studied: Parkinson's Disease (PD)
In brief
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).
Key facts
- Study ID
- NCT02799381
- Run by
- AbbVie
- People needed
- 63
- Starts
- 2017-02-09
- Expected to finish
- 2019-09-19
- Last updated by the study team
- 2020-08-18
Who can join
Age: 30 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
Full record on ClinicalTrials.gov
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