Phase 3
Completed N=354
Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT00335153 ↗
Enrolled (actual)
354
Serious AEs
30.5%
Results posted
Jan 2015
Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs — 8; 7; 111; 108 participants
Summary
The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs |
8; 7; 111; 108; 27; 323 | — |
| PRIMARY Number of Participants With Device Complications During the Nasojejunal (NJ) Test Period |
90; 7; 4; 68; 25 | — |
| PRIMARY Number of Participants With Device Complications During the Percutaneous Endoscopic Gastrostomy - With Jejunal Extension Tube (PEG-J) Surgery and Post-PEG Long Term Treatment Periods |
282; 116; 165; 114; 116; 114 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Values for Hematology Parameters |
0; 4; 27; 3; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters |
1; 0; 3; 0; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Sign Parameters |
4; 17; 2; 35; 80; 5 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters |
1; 1; 6; 26; 15; 4 | — |
| PRIMARY Number of Participants With Sleep Attacks at Baseline |
7; 4; 0; 0; 2; 1 | — |
| PRIMARY Number of Participants With Sleep Attacks During the Post-PEG Long-Term Treatment Period |
27; 11; 2; 5; 9; 11 | — |
| PRIMARY Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and During the Post-PEG Long-term Treatment (PPLT) Period |
0; 0; 0; 0; 0; 2 | — |
| PRIMARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint |
9.6; -1.7 | — |
| PRIMARY Number of Participants With Confirmed Cases of Melanoma |
— | — |
| PRIMARY Number of Participants Taking at Least 1 Concomitant Medication During the Study |
349 | — |
| SECONDARY Change From Baseline in Average Daily "Off" Time at Endpoint |
6.77; -4.44 | <0.001 sig |
| SECONDARY Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint |
1.60; -0.36 | 0.023 sig |
| SECONDARY Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Endpoint |
4.83; 3.86 | <0.001 sig |
| SECONDARY Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint |
4.85; 2.10 | <0.001 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Month 12 |
2.2; 0.0 | 0.974 |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint |
17.5; -4.4 | <0.001 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint |
28.9; -7.4 | <0.001 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint |
48.6; -11.7 | <0.001 sig |
| SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint |
9.2; -3.5 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint |
42.7; -6.9 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint |
58.8; -11.2 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint |
50.7; -8.3 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint |
39.4; -4.2 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint |
32.5; -9.1 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint |
17.2; -0.3 | 0.757 |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint |
27.2; -4.5 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint |
34.3; -3.9 | <0.001 sig |
| SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint |
46.2; -5.8 | <0.001 sig |
| SECONDARY Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint |
0.588; 0.064 | <0.001 sig |
| SECONDARY Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint |
50.2; 14.0 | <0.001 sig |
| SECONDARY Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint |
27.1; 0.2 | 0.824 |
Eligibility Criteria
Inclusion Criteria
- Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
- Levodopa-responsive with severe motor fluctuations
- Recognizable off and on state (motor fluctuations) confirmed by diary
Exclusion Criteria
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as secondary parkinsonism
- Undergone surgery for the treatment of PD
- Contraindications to levodopa (such as narrow angle glaucoma)
Data sourced from ClinicalTrials.gov (NCT00335153). 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.