To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.
This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
630
Active comparator - IR CD-LD
Investigational formulation - ER CD-LD
Double dummy placebo capsules
Mean Change From Baseline in "Good on" Time Per Day at Week 20/Early Termination (ET)
"Good on" time was derived from the 3-day PD Diaries. For each day, "Good on" time was calculated by adding the number of half-hour intervals in which either an "On" without dyskinesia or "On" with nontroublesome dyskinesia was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. Least square mean (LSM), standard error (SE), confidence interval (CI), Mixed model repeated measures (MMRM), Change from baseline (CFB).
Time frame: Baseline (Week 7) and Week 20/ET
Change From Baseline in "Off" Time Per Day at Week 20/ET
"Off" time was derived from the 3-day PD Diaries. For each day, "Off" time was calculated by adding the number of half-hour intervals in which the Status "Off" was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Time frame: Baseline (Week 7) and Week 20/ET
Percentage of Participants With Either "Much Improved" or "Very Much Improved" in Patient Global Impression of Change (PGI-C) Scores at Week 20/ET
The Patient Global Impression of Change (PGIC) is self assessment questionnaire which was used by participants to compare his/her condition on a 7-point scale ranging from 1-Very Much Worse, 2-Much Worse, 3-Minimally Worse, 4-No Change, 5-Minimally Improved, 6-Much Improved, 7-Very Much Improved. Percentage of participants with either "Much Improved" or "Very Much Improved" was reported.
Time frame: Week 20/ET
Change From Baseline in The Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Week 20/ET
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 34 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-234). Part III score ranges from 0 to 136. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
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Double dummy placebo tablets
Xenoscience, Inc. (102)
Phoenix, Arizona, United States
St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156)
Phoenix, Arizona, United States
Clinical Trials, Inc. (113)
Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences (117)
Little Rock, Arkansas, United States
Loma Linda University Health Care, Department of Neurology (137)
Loma Linda, California, United States
Keck School of Medicine of USC/University of Southern California (106)
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian (134)
Newport Beach, California, United States
SC3 Research - Pasadena (148)
Pasadena, California, United States
SC3 Research - Reseda (146)
Reseda, California, United States
University of Colorado Hospital Anschutz Outpatient Pavilion (120)
Aurora, Colorado, United States
...and 98 more locations
Time frame: Baseline (Week 7) and Week 20/ET
Change From Baseline in The Sum of MDS-UPDRS Part II and Part III at Week 20/ET
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 34 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-234). The scale range for Part II+III score is 0-188. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization.
Time frame: Baseline (Week 7) and Week 20/ET