Clinical trial NCT02799381: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease (PD)
Keywords: Carbidopa
Levodopa
Efficacy
Levodopa-carbidopa intestinal gel
Advanced Parkinson's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-14
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: This was a Phase 3b, open-label, randomized, multicenter, 12-week study. The study consisted of 3 sequential periods: Screening, Treatment, and Follow-Up. The OMT group had the same schedule of visits/procedures throughout the study as the LCIG treatment group, except for visits related to nasojejunal (NJ)/percutaneous endoscopic gastrostomy (PEG) procedures, titration of LCIG, and follow-up period.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index
timeFrame: Baseline, Week 12
measure: Mean Clinical Global Impression of Change (CGI-C) Score at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living)
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline to Week 12 in OFF Time
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095
state: Florida
city: Round Rock
country: United States
facility: Central Texas Neurology Consul /ID# 150088
state: Texas
city: Helsinki
country: Finland
facility: Helsinki Univ Central Hospital /ID# 151214
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala /ID# 150947
city: Glyfada
country: Greece
facility: Mediterraneo Hospital /ID# 150955
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion "PA.G.N.I" /ID# 150956
city: Ioannina
country: Greece
facility: University Hospital of Ioannin /ID# 150954
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116
state: Pecs
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 170117
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem /ID# 170115
city: Rome
country: Italy
facility: Policlinico Universitario Campus Bio-Medico /ID# 150846
state: Lazio
city: Ancona
country: Italy
facility: A.O. Univ. Ospedali Riuniti /ID# 150853
state: Marche
city: Florence
country: Italy
facility: Azienda USL Toscana Centro /ID# 150770
city: Naples
country: Italy
facility: Seconda Universita' di Napoli /ID# 150851
city: Rome
country: Italy
facility: Policlinico Tor Vergata /ID# 151167
city: Košice - Západ
country: Slovakia
facility: Univerzitna nemocnica L. Pasteura /ID# 150146
state: Kosicky Kraj
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin /ID# 150145
state: Zilinsky Kraj
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica Bratislava /ID# 150144
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica Bratislava /ID# 150171
city: Málaga
country: Spain
facility: Hospital Regional Universitari /ID# 171485
state: Malaga
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces /ID# 203807
city: Elche
country: Spain
facility: Hospital General Univ de Elche /ID# 150154
city: Madrid
country: Spain
facility: Hospital Univ de la Princesa /ID# 150157
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 150155
city: Madrid
country: Spain
facility: Hospital Univ Ramon y Cajal /ID# 150152
city: Madrid
country: Spain
facility: Hospital Universitario Infanta /ID# 159696
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena /ID# 158861
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud /ID# 166297
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.