NCT02006121

Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's Disease

Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Britannia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment. The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

Detailed description

The primary efficacy variable is the mean change in time spent "OFF" from baseline (start of blinded treatment) to the end of a 12 weeks' double-blind treatment period based on patient diaries. Patients recorded their motor symptoms in half-hour blocks as OFF, ON without dyskinesia, ON without troublesome dyskinesia, or sleeping using the Hauser Parkinson's Disease home diary. Key secondary Endpoints (tested hierarchically): * Change in time spent "ON without troublesome dyskinesia" * Patient Global Impression of Change Other Endpoints: * Percentage of patients with response to therapy, defined as a mean OFF time reduction of at least 2 hours * Change in oral levodopa and levodopa equivalent dose

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Apomorphine hydrochloride	Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
DRUG	Placebo	Sodium chloride 9 mg/ml

Timeline

• Start date: 2014-03-03
• Primary completion: 2016-06-06
• Completion: 2017-06-08
• First posted: 2013-12-09
• Last updated: 2019-07-08
• Results posted: 2019-07-08

Locations

20 sites across 7 countries: Austria, Denmark, France, Germany, Netherlands, Spain, United Kingdom