NCT02339064

Infusion of Apomorphine: Long-term Safety Study

A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, 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.

Detailed description

This Phase 3, multicenter, open-label study will assess the long-term safety and tolerability of continuous subcutaneous infusion of apomorphine in advanced Parkinson's disease (PD) patients whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD. Further, this study will assess the clinical effectiveness of continuous apomorphine subcutaneous infusion in reducing "off" time in advanced PD patients and to assess the clinical effectiveness of continuous subcutaneous infusion of apomorphine in improving "on" time without resulting in an increase in troublesome dyskinesias.

Conditions

• Idiopathic Parkinson's Disease

Interventions

Type	Name	Description
DRUG	apomorphine infusion	Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-12-01
• Completion: 2025-12-01
• First posted: 2015-01-15
• Last updated: 2025-06-19

Locations

18 sites across 1 country: United States