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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)

NCT02799381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2020-08-18

Study results available
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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).

Conditions

  • Parkinson's Disease (PD)

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-09
Primary Completion
2019-09-19
Completion
2019-09-19
FDA Drug
Yes

Countries

  • United States
  • Finland
  • Greece
  • Hungary
  • Italy
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02799381 on ClinicalTrials.gov