Phase 3
Completed N=262
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Advanced Parkinson's Disease
Source: ClinicalTrials.gov NCT00660673 ↗
Enrolled (actual)
262
Serious AEs
60.7%
Results posted
Dec 2022
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events — 253; 219; 159; 152 Participants
◆ Published Evidence
Established
93citations · ~12 / year
Long-term safety and efficacy of levodopa-carbidopa intestinal gel in advanced Parkinson's disease.
Summary
The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study S187.3.004 [NCT00335153]).
Linked Publications
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Long-term safety and efficacy of levodopa-carbidopa intestinal gel in advanced Parkinson's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events |
253; 219; 159; 152; 82; 58 | — |
| SECONDARY Number of Participants With Device Complications |
244; 183; 177; 43 | — |
| SECONDARY Number of Participants With Sleep Attacks |
6; 0; 27; 3 | — |
| SECONDARY Number of Participants With Intense Impulsive Behavior |
1; 0; 0; 0; 0; 1 | — |
| SECONDARY Number of Participants Who Developed Melanoma |
2 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI) |
162; 24; 53; 7; 71 | — |
| SECONDARY Number of Participants With Any Suicidal Ideation or Behavior |
32; 30; 6; 1 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Vital Sign Values |
6; 13; 1; 26; 73; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Hematology Laboratory Values |
0; 9; 16; 3; 2; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Vitamin Levels Outside of the Normal Range |
22; 46; 65; 1; 198; 155 | — |
| SECONDARY Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year |
126; 107; 96; 74; 52; 38 | — |
| SECONDARY Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment |
-3.97; -0.19 | <0.001 sig |
| SECONDARY Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment |
3.86; -0.51 | <0.001 sig |
| SECONDARY Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment |
0.12; 0.70 | 0.725 |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment |
1.51; 1.46 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment |
3.04; 6.11 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment |
4.51; 9.18 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment |
9.12; 16.82 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment |
-2.27; 0.77 | — |
| SECONDARY Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment |
-0.19; 0.55 | — |
| SECONDARY Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment |
-1.46; 6.83; -2.08; 12.01; -1.55; 9.35 | — |
Eligibility Criteria
Inclusion Criteria
- The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG.
- For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
- The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations.
Exclusion Criteria
- Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.
Data sourced from ClinicalTrials.gov (NCT00660673) and the linked publication. 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.