Status:
Active, No Longer Recruiting
Clinicaltrials.gov identifier:
Sponsor:
US WorldMeds
Enrollment:
99
Study Design:
This is a Phase 3, multicentre (18 locations), open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson’s Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.
Rationale:
The primary outcome is the percentage of OFF time during the waking day at week 12 compared to baseline. Secondary outcome measures are all based on efficacy: 1. Percent of daily “on” time without troublesome dyskinesias during waking day, baseline to Week 12; 2. Percent of daily “off” time during the waking day, baseline to weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 3. Percent of daily “on” time without troublesome dyskinesias during the waking day, baseline to weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 4. Percent of daily “on” time without dyskinesias, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 5. UPDRS - Motor Score, baseline visit to week 12; 6. Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all treatment extension period visits; 7. Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 8. Parkinson’s Disease Questionnaire, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 9. UPDRS - Activities of Daily Living Score, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 10. Proportion of responders, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits; 11. Frequency and total dose of average daily intermittent injection of APOKYN for subjects on APOKYN treatment at study entry, baseline visit to treatment weeks 2, 4, 8, 20, 28, 36, 44, and 52, and all treatment extension period visits.
Comments:
The INFUS-ON trial is aiming to recruit patients with advanced idiopathic PD, with unsatisfactory motor control despite optimised treatment and OFF periods ≥3 hours per day.
Apomorphine is well accepted as efficacious in the treatment of OFF episodes in advanced PD and the rationale for continuous s.c. delivery makes sense. Hopefully, this study will enable drug approval in the US after many years of successful utilization in Europe.
