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)
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - Any |
Updated: | 3/9/2019 |
Start Date: | February 9, 2017 |
End Date: | January 30, 2020 |
Contact: | ABBVIE CALL CENTER |
Email: | abbvieclinicaltrials@abbvie.com |
Phone: | 847.283.8955 |
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)
The primary objective of this study is 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).
gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with
advanced Parkinson's disease (PD).
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:
- Patient(s) treated with LCIG previously
- Patient'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
- Patient(s) has undergone neurosurgery for the treatment of Parkinson's disease.
- Patient(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant
melanoma)
- Patient(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
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