Phase 3
N=61
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)
Parkinson's Disease (PD)
Bottom Line
View on ClinicalTrials.gov: NCT02799381 ↗Enrolled (actual)
61
Serious AEs
3.3%
Results posted
Aug 2020
Primary outcome: Primary: Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score — -2.33; -17.37 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Optimized antiparkinsonian treatment (Drug); Levodopa-Carbidopa Intestinal Gel (LCIG) (Drug); CADD-Legacy ambulatory infusion pump (Device); Percutaneous endoscopic gastrostomy tube (Device); Jejunal extension tube (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score |
-2.33; -17.37 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia |
-0.12; 3.15 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index |
-4.95; -21.62 | <0.0001 sig |
| SECONDARY Mean Clinical Global Impression of Change (CGI-C) Score at Week 12 |
4.58; 2.48 | <0.0001 sig |
| SECONDARY Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) |
0.21; -5.33 | =0.0006 sig |
| SECONDARY Mean Change From Baseline to Week 12 in OFF Time |
0.18; -2.17 | =0.0002 sig |
| SECONDARY Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination) |
-0.87; -4.93 | =0.0762 |
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).
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
Data sourced from ClinicalTrials.gov (NCT02799381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.