Phase 3
Completed N=89
A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT02549092 ↗
Enrolled (actual)
89
Serious AEs
14.4%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline to Week 26 in the NMSS Total Score — -23.83; -32.04 score on a scale — p=0.410
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to examine the effect of LCIG relative to that of OMT on NMS associated with PD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 26 in the NMSS Total Score |
-23.83; -32.04 | 0.410 |
| PRIMARY Change From Baseline to Week 26 in the Modified PDSS-2 Total Score |
-8.98; -7.41 | 0.509 |
| SECONDARY Change From Baseline to Week 26 in Parkinson's Disease Questionnaire (PDQ-8) Summary Index Score |
-1.75; -5.56 | 0.291 |
| SECONDARY Clinical Global Impression of Change (CGI-C) Final Score |
4.9; 2.5 | < 0.001 sig |
| SECONDARY Change From Baseline at Week 26 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score |
0.53; -2.26 | 0.006 sig |
| SECONDARY Change From Baseline to Week 26 in the NMSS Domain Scores |
-1.84; -1.76; -7.11; -6.06; -5.99; -7.84 | 0.933 |
| SECONDARY Change From Baseline to Week 26 in the Modified PDSS-2 Domain Scores |
-2.21; -2.79; -1.77; -1.53; -4.88; -2.89 | 0.643 |
| SECONDARY Change From Baseline at Week 26 in UPDRS Parts I, III, and IV Score |
0.20; 0.39; 1.32; -0.89; -0.61; -2.31 | 0.672 |
| SECONDARY Change From Baseline at Week 26 in Parkinson's Anxiety Scale (PAS) Total Score |
-0.75; -2.29 | 0.307 |
| SECONDARY Change From Baseline at Week 26 in Geriatric Depression Scale (GDS-15) Score |
0.25; 0.17 | 0.868 |
| SECONDARY Change From Baseline at Week 26 in King's PD Pain Scale (KPPS) Score |
-11.32; -12.46; -1.72; -1.79; -0.84; -0.77 | 0.728 |
| SECONDARY Patient Global Impression of Change (PGIC) Final Score |
4.9; 2.5 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant(s) must have a diagnosis of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria.
- Participant(s) demonstrates persistent motor fluctuations in spite of individually optimized treatment.
- The participant's Parkinson's disease is levodopa-responsive.
- Participant(s) has had optimized treatment with available anti-PD medication and their motor symptoms are judged inadequately controlled on this optimized treatment. Optimized treatment is defined as the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected regardless of any additional manipulations of levodopa and/or other antiparkinsonian medication. This will be based on the Investigator's clinical judgment.
- Male or female participant(s) must be at least 30 years of age.
- Minimum Parkinson's Disease Sleep Scale 2 (PDSS-2) total score of 18 at Baseline assessment.
Exclusion Criteria
- 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.
- Known hypersensitivity to levodopa, carbidopa or radiopaque material.
- 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 (NCT02549092). 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. Informational only — not medical advice.