CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Optimized antiparkinsonian treatment +4 moredrug
Likely dose
Levodopa-Carbidopa Intestinal Gel at individually optimized dose levelsAI-extracted
Key inclusion· 3
  • Idiopathic Parkinson's disease diagnosed according to UK Parkinson's Disease Society Brain Bank Criteria
  • Advanced levodopa-responsive PD with persistent motor fluctuations inadequately controlled by optimized medical treatment
  • Unified Dyskinesia Rating Scale (UDysRS) Total score ≥30
Key exclusion· 5
  • Prior treatment with Levodopa-Carbidopa Intestinal Gel (LCIG)
  • Uncertain PD diagnosis or suspicion of parkinsonian syndrome (secondary parkinsonism, parkinson-plus syndrome, other neurodegenerative disease)
  • Prior neurosurgery for Parkinson's disease treatment
  • Contraindications to levodopa (e.g., narrow angle glaucoma, malignant melanoma)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02799381
NCT02799381Phase 3Completed

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)

AbbVie·interventional·Posted Jun 14, 2016·Updated Aug 18, 2020

In Brief

A Phase 3 clinical trial evaluating Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG), and 3 other interventions for Parkinson's Disease (PD). Completed, enrolled 63 participants across 28 sites in 7 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland, Greece, Hungary, Italy, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 14, 2016
Enrollment StartFeb 9, 2017
Primary CompletionSep 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.0 years ago

Interventions

Optimized antiparkinsonian treatmentdrug

Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.

Levodopa-Carbidopa Intestinal Gel (LCIG)drug

Dose levels were individually optimized.

CADD-Legacy ambulatory infusion pumpdevice

(manufactured by Smiths Medical)

Percutaneous endoscopic gastrostomy tubedevice

(PEG tube)

Jejunal extension tubedevice

(J-tube)