Trials / Completed
CompletedNCT02799381
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)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Optimized antiparkinsonian treatment | Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect. |
| DRUG | Levodopa-Carbidopa Intestinal Gel (LCIG) | Dose levels were individually optimized. |
| DEVICE | CADD-Legacy ambulatory infusion pump | (manufactured by Smiths Medical) |
| DEVICE | Percutaneous endoscopic gastrostomy tube | (PEG tube) |
| DEVICE | Jejunal extension tube | (J-tube) |
Timeline
- Start date
- 2017-02-09
- Primary completion
- 2019-09-19
- Completion
- 2019-09-19
- First posted
- 2016-06-14
- Last updated
- 2020-08-18
- Results posted
- 2020-08-18
Locations
28 sites across 7 countries: United States, Finland, Greece, Hungary, Italy, Slovakia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02799381. Inclusion in this directory is not an endorsement.