Phase 3
Completed N=39
A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT01736176 ↗
Enrolled (actual)
39
Serious AEs
20.5%
Results posted
Feb 2017
Primary outcomePrimary: Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score — -17.6 units on a scale — p=< 0.001
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 evaluate change in non-motor symptoms from baseline to Week 12 as measured by the Non-Motor Symptom Scale total score.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score |
-17.6 | < 0.001 sig |
| SECONDARY Number of Participants Who Used Healthcare Resources During the First 4 Weeks |
3; 0; 6; 11; 8; 9 | — |
| SECONDARY Number of Participants With Adverse Events |
28; 37; 26; 35; 4; 11 | — |
| SECONDARY Number of Participants Who Used Healthcare Resources Through Week 60 |
1; 18; 3; 1; 1; 1 | — |
| SECONDARY Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score |
-11.8 | 0.004 sig |
| SECONDARY Change From Baseline in NMSS Cardiovascular Domain Score |
-0.2; 0.5 | — |
| SECONDARY Change From Baseline in NMSS Sleep/Fatigue Domain Score |
-6.0; -5.4 | — |
| SECONDARY Change From Baseline in NMSS Mood/Cognition Domain Score |
0.0; 0.5 | — |
| SECONDARY Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score |
-0.5; 0.4 | — |
| SECONDARY Change From Baseline in NMSS Attention/Memory Domain Score |
-2.1; -2.2 | — |
| SECONDARY Change From Baseline in NMSS Gastrointestinal Tract Domain Score |
-2.0; -1.9 | — |
| SECONDARY Change From Baseline in NMSS Urinary Domain Score |
-2.2; 0.1 | — |
| SECONDARY Change From Baseline in NMSS Sexual Function Domain Score |
-1.8; -1.1 | — |
| SECONDARY Change From Baseline in NMSS Miscellaneous Domain Score |
-3.4; -3.4 | — |
| SECONDARY Change From Baseline in Mean Daily Normalized "Off" Time Based on Parkinson's Disease Diary |
-4.1; -4.9 | — |
| SECONDARY Change From Baseline in Mean Daily Normalized "On" Time Without Troublesome Dyskinesia Based on PD Diary |
3.7; 4.3 | — |
| SECONDARY Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score |
-11.4; -7.7 | — |
| SECONDARY Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score |
-0.3; -0.1 | — |
| SECONDARY Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score |
-5.5; -4.7 | — |
| SECONDARY Change From Baseline in UPDRS Part III: Motor Examination Score |
-5.6; -3.6 | — |
| SECONDARY Change From Baseline in UPDRS Part IV: Complications of Therapy Score |
-3.5; -2.9 | — |
| SECONDARY Change From Baseline in UPDRS Dyskinesia Items Score |
-1.1; -0.6 | — |
| SECONDARY Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score |
-0.2; -0.2 | — |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index |
-11.2; -10.2 | — |
| SECONDARY Change From Baseline in PDQ-39 Mobility Domain Score |
-18.5; -19.4 | — |
| SECONDARY Change From Baseline in PDQ-39 Activities of Daily Living Domain Score |
-12.1; -11.9 | — |
| SECONDARY Change From Baseline in PDQ-39 Emotional Well-Being Domain Score |
-4.9; -6.6 | — |
| SECONDARY Change From Baseline in PDQ-39 Stigma Domain Score |
-9.5; -5.4 | — |
| SECONDARY Change From Baseline in PDQ-39 Social Support Domain Score |
1.6; 3.3 | — |
| SECONDARY Change From Baseline in PDQ-39 Cognition Domain Score |
-8.4; -7.3 | — |
| SECONDARY Change From Baseline in PDQ-39 Communication Domain Score |
-13.0; -10.8 | — |
| SECONDARY Change From Baseline in PDQ-39 Bodily Discomfort Domain Score |
-9.6; -3.8 | — |
| SECONDARY Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved |
78.9; 71.1 | — |
| SECONDARY Treatment Satisfaction Questionnaire Scores |
15; 14; 14; 9; 4; 3 | — |
| SECONDARY Change From Baseline in Health-related Productivity |
-2.1; -5.2; -3.5; -1.9; -0.8; -0.3 | — |
| SECONDARY Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12 |
-0.6 | — |
| SECONDARY Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12 |
0.8 | — |
| SECONDARY Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60 |
-0.5; -1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- Demonstrate persistent motor fluctuations in spite of individually optimized treatment
- Subject must experience a minimum of 3 hours "Off" time
Exclusion Criteria
- Subject'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, Corticobasilar Degeneration), or other neurodegenerative disease that might mimic the symptoms of PD.
- Subject has undergone neurosurgery for the treatment of Parkinson's disease
- Subject for whom the placement of a PEG-J tube for LCIG treatment is contraindicated or is considered a high risk for the PEG-J procedure according to the gastroenterology evaluation (e.g., pathological changes of the gastric wall, inability to bring the gastric wall and abdominal wall together, blood coagulation disorders, peritonitis, acute pancreatitis, paralytic ileus).
Data sourced from ClinicalTrials.gov (NCT01736176). 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.