Trial · NCT02799381
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, Phase 3, Completed, AbbVie; results first posted 2020-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT02799381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02799381
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT02799381
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 63 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Parkinson's Disease (PD)
- Interventions
- Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG), CADD-Legacy ambulatory infusion pump, Percutaneous endoscopic gastrostomy tube, Jejunal extension tube
- First posted
- 2016-06-14
- Last updated
- 2020-08-18
- Other registries' IDs
- eudract:2016-001403-23
- Results first posted
- 2020-08-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score | Baseline, Week 12 | The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement. |
| Secondary | Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia | Baseline, Week 12 | The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Positive change from baseline for ON time without troublesome dyskinesia indicates improvement. |
| Secondary | Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index | Baseline, Week 12 | The Parkinson's Disease Questionnaire-8 (PDQ-8) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. The PDQ-8 is a self-administered questionnaire. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Higher scores are consistently associated with the more severe symptoms of the disease such as tremors and stiffness. The results are presented as a summary index. The PDQ-8 summary index ranges from 0 to 100, where lower scores indicate a better perceived health status. Negative changes from baseline indicate improvement. |
| Secondary | Mean Clinical Global Impression of Change (CGI-C) Score at Week 12 | Baseline, Week 12 | The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement. |
| Secondary | Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) | Baseline, Week 12 | The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Negative values indicate improvement from baseline. |
| Secondary | Mean Change From Baseline to Week 12 in OFF Time | Baseline, Week 12 | The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Negative change from baseline for OFF time indicates improvement. |
| Secondary | Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination) | Baseline, Week 12 | The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. Higher scores are associated with more disability. Negative values indicate improvement from baseline. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Clinical Global Impression of Change (CGI-C) Score at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 12 in OFF Time | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination) | Baseline, Week 12 | Intent-to-treat (ITT) population: all participants with available data who were randomized to the OMT and all participants who were randomized to LCIG treatment and received at least 1 dose of study drug following PEG-J placement | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score | Optimized Medical Treatment (OMT) | -2.33 | Standard Error 2.56 | units on a scale | |
| Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score | Levodopa-Carbidopa Intestinal Gel (LCIG) | -17.37 | Standard Error 2.79 | units on a scale | |
| Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia | Optimized Medical Treatment (OMT) | -0.12 | Standard Error 0.63 | hours | |
| Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia | Levodopa-Carbidopa Intestinal Gel (LCIG) | 3.15 | Standard Error 0.69 | hours | |
| Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index | Optimized Medical Treatment (OMT) | -4.95 | Standard Error 3.11 | units on a scale | |
| Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index | Levodopa-Carbidopa Intestinal Gel (LCIG) | -21.62 | Standard Error 3.47 | units on a scale | |
| Mean Clinical Global Impression of Change (CGI-C) Score at Week 12 | Optimized Medical Treatment (OMT) | 4.58 | Standard Error 0.25 | units on a scale | |
| Mean Clinical Global Impression of Change (CGI-C) Score at Week 12 | Levodopa-Carbidopa Intestinal Gel (LCIG) | 2.48 | Standard Error 0.28 | units on a scale | |
| Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) | Optimized Medical Treatment (OMT) | 0.21 | Standard Error 1.16 | units on a scale | |
| Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living) | Levodopa-Carbidopa Intestinal Gel (LCIG) | -5.33 | Standard Error 1.28 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Optimized Medical Treatment (OMT) | 33 | |
| Overall Study | STARTED | Levodopa-Carbidopa Intestinal Gel (LCIG) | 28 | |
| Overall Study | COMPLETED | Optimized Medical Treatment (OMT) | 29 | |
| Overall Study | COMPLETED | Levodopa-Carbidopa Intestinal Gel (LCIG) | 25 | |
| Overall Study | NOT COMPLETED | Optimized Medical Treatment (OMT) | 4 | |
| Overall Study | NOT COMPLETED | Levodopa-Carbidopa Intestinal Gel (LCIG) | 3 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Levodopa-Carbidopa Intestinal Gel (LCIG) | 2 | 28 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Optimized Medical Treatment (OMT) | 0 | 33 | 0 |
| other | DIARRHOEA | Gastrointestinal disorders | Levodopa-Carbidopa Intestinal Gel (LCIG) | 2 | 28 | 2 |
| other | DIARRHOEA | Gastrointestinal disorders | Optimized Medical Treatment (OMT) | 0 | 33 | 0 |
| other | DRUG WITHDRAWAL SYNDROME | General disorders | Levodopa-Carbidopa Intestinal Gel (LCIG) | 2 | 28 | 2 |
| other | DRUG WITHDRAWAL SYNDROME | General disorders | Optimized Medical Treatment (OMT) | 0 | 33 | 0 |
| other | URINARY TRACT INFECTION | Infections and infestations | Levodopa-Carbidopa Intestinal Gel (LCIG) | 2 | 28 | 2 |
| other | URINARY TRACT INFECTION | Infections and infestations | Optimized Medical Treatment (OMT) | 0 | 33 | 0 |
| other | FALL | Injury, poisoning and procedural complications | Levodopa-Carbidopa Intestinal Gel (LCIG) | 6 | 28 | 6 |
| other | FALL | Injury, poisoning and procedural complications | Optimized Medical Treatment (OMT) | 2 | 33 | 3 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levodopa-Carbidopa Intestinal Gel (LCIG) | 0 | 28 |
| Total, all-cause mortality | Optimized Medical Treatment (OMT) | 0 | 33 |
| Total, other adverse events | Levodopa-Carbidopa Intestinal Gel (LCIG) | 15 | 28 |
| Total, other adverse events | Optimized Medical Treatment (OMT) | 4 | 33 |
| Total, serious adverse events | Levodopa-Carbidopa Intestinal Gel (LCIG) | 2 | 28 |
| Total, serious adverse events | Optimized Medical Treatment (OMT) | 0 | 33 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Levodopa-Carbidopa Intestinal Gel (LCIG) vs Optimized Medical Treatment (OMT): deaths from any cause | Trial comparisons |
| Levodopa-Carbidopa Intestinal Gel (LCIG) vs Optimized Medical Treatment (OMT): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02799381
GET https://conductscience.org/api/trials/v1/NCT02799381/events?page=2