Phase 3 Completed N=62 Treatment

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Dyskinesias · Parkinson's Disease · Severe Motor Fluctuations

Source: ClinicalTrials.gov NCT00360568 ↗

Enrolled (actual)

Serious AEs

22.6%

Results posted

Jan 2015

Primary outcomePrimary: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs — 0; 0; 0; 0 participants

Summary

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Device Complications	26; 24; 50; 18; 16; 34	—
PRIMARY Number of Participants With Potentially Clinically Significant Values for Hematology Parameters	0; 0; 0; 0; 1; 1	—
PRIMARY Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Potentially Clinically Significant Vital Sign Parameters	3; 0; 3; 1; 2; 3	—
PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Sleep Attacks at Baseline and Endpoint	0; 0; 0; 0; 0; 0	—
PRIMARY Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)	0; 0; 0; 0; 0; 0	—
PRIMARY Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint	6.1; 5.3; 5.7; 6.1; 5.0; 5.6	—
PRIMARY Number of Participants With Confirmed Cases of Melanoma	0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Neurological Examination Findings	0; 0; 0; 3; 2; 5	—
PRIMARY Columbia-Suicide Severity Rating Scale (C-SSRS) Findings	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants Taking at Least 1 Concomitant Medication During the Study	33; 29; 62	—
SECONDARY Change From Baseline in Average Daily "Off" Time at Endpoint	2.87; 5.18; 3.92; -0.42; -2.34; -1.30	<0.001 sig
SECONDARY Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint	1.09; 0.82; 0.97; -0.58; 0.15; -0.24	0.394
SECONDARY Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12	12.04; 10.00; 11.11; 1.00; 2.19; 1.54	<0.001 sig
SECONDARY Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint	3.0; 3.7; 3.3; 2.1; 2.3; 2.2	<0.001 sig
SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint	1.6; 1.2; 1.4; 0.3; 0.7; 0.5	0.055
SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint	8.6; 12.1; 10.1; 0.5; -1.0; -0.2	0.766
SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint	16.2; 19.0; 17.4; 1.5; -0.5; 0.6	0.571
SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint	26.4; 32.4; 29.0; 2.3; -1.0; 0.9	0.583
SECONDARY Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint	5.8; 7.0; 6.3; -1.6; -1.4; -1.5	<0.001 sig
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint	22.2; 32.8; 26.9; 1.5; -3.5; -0.7	0.670
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint	27.6; 43.8; 34.7; 2.3; -8.5; -2.5	0.341
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint	25.9; 39.4; 31.9; 0.4; -6.7; -2.8	0.220
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint	20.1; 26.3; 22.8; 4.0; 1.9; 3.1	0.174
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint	16.4; 23.8; 19.7; 0.2; -6.3; -2.7	0.259
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint	11.9; 17.1; 14.2; 1.8; -2.7; -0.2	0.922
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint	15.0; 24.8; 19.3; 1.3; 3.8; 2.4	0.258
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint	15.9; 31.7; 22.9; 8.3; -1.9; 3.8	0.104
SECONDARY Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint	32.1; 34.9; 33.3; -2.8; 1.0; -1.1	0.650
SECONDARY Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint	0.778; 0.676; 0.733; -0.009; -0.006; -0.008	0.759
SECONDARY Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint	76.7; 62.1; 70.2; -0.9; 4.5; 1.5	0.459
SECONDARY Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint	22.1; 27.0; 24.3; 1.1; -1.8; -0.2	0.899

Eligibility Criteria

Inclusion Criteria

Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease Society (UKPDS) Brain Bank Criteria
Levodopa-responsive with severe motor fluctuations
Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study

Exclusion Criteria

Patients with medically relevant abnormal findings (labs, electrocardiogram [ECG], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00360568). 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.