Prequalified raters completed training and were certified to administer efficacy scales. Rater training utilized the MDS teaching modules for the Unified Dyskinesia Rating Scale (UDysRS) and MDS‐UPDRS. If possible, the same rater conducted efficacy assessments for a patient at least 30 minutes following the patient's regularly scheduled levodopa dose, and when the patient was ON (PD medications providing good effect on motor symptoms) and experiencing typical dyskinesia. There were up to 9 visits (Screening, Baseline, weeks 1, 2, 4, 8, 12, 13, and safety follow‐up visits) in this study. Study visits and assessments were scheduled between 9:00 am and 4:00 pm , and all study visits for an individual participant were to be scheduled at approximately the same time of day. Doses and regimens of antiparkinson medications were maintained without changes during study participation.
During screening (up to 3 weeks prior to baseline), written informed consent was obtained, training and concordance testing for the PD home diary was completed, and study eligibility criteria were assessed. A set of two 24‐hour PD home diaries was distributed for completion just prior to the scheduled baseline visit. During the baseline visit (week 0, day 1), study eligibility was confirmed and patients were randomized to ADS‐5102 or placebo.
In addition, the following efficacy assessments were completed: UDysRS, review of completed PD home diaries, MDS‐UPDRS, and baseline notes to allow future assessment of the Clinician's Global Impression of Change (CGI‐C).
During the first week of dosing, patients randomized to ADS‐5102 received a daily ADS‐5102 dose of 137 mg (one ADS‐5102–containing capsule and one placebo capsule, identical in appearance). During weeks 2 through 12, the daily ADS‐5102 dose was 274 mg, administered as two 137‐mg capsules. During the last week of dosing, the dose was reduced to 137 mg daily. Patients randomized to placebo received 2 placebo capsules for 13 weeks. Individuals who discontinued the study drug were encouraged to continue study participation and complete all study visits.
The UDysRS, MDS‐UPDRS, CGI‐C, and standard safety assessments were performed at weeks 2, 4, 8, and 12. The PD home diaries were completed prior to each of these visits. A final safety follow‐up visit occurred approximately 7 days following treatment completion unless a patient elected to enroll directly into a companion open‐label safety study (NCT02202551).30
During screening (up to 3 weeks prior to baseline), written informed consent was obtained, training and concordance testing for the PD home diary was completed, and study eligibility criteria were assessed. A set of two 24‐hour PD home diaries was distributed for completion just prior to the scheduled baseline visit. During the baseline visit (week 0, day 1), study eligibility was confirmed and patients were randomized to ADS‐5102 or placebo.
In addition, the following efficacy assessments were completed: UDysRS, review of completed PD home diaries, MDS‐UPDRS, and baseline notes to allow future assessment of the Clinician's Global Impression of Change (CGI‐C).
During the first week of dosing, patients randomized to ADS‐5102 received a daily ADS‐5102 dose of 137 mg (one ADS‐5102–containing capsule and one placebo capsule, identical in appearance). During weeks 2 through 12, the daily ADS‐5102 dose was 274 mg, administered as two 137‐mg capsules. During the last week of dosing, the dose was reduced to 137 mg daily. Patients randomized to placebo received 2 placebo capsules for 13 weeks. Individuals who discontinued the study drug were encouraged to continue study participation and complete all study visits.
The UDysRS, MDS‐UPDRS, CGI‐C, and standard safety assessments were performed at weeks 2, 4, 8, and 12. The PD home diaries were completed prior to each of these visits. A final safety follow‐up visit occurred approximately 7 days following treatment completion unless a patient elected to enroll directly into a companion open‐label safety study (NCT02202551).
