CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
Apomorphine hydrochloride +1 moredrug
Likely dose
Apomorphine hydrochloride 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02006121
NCT02006121Phase 3Completed

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

Britannia Pharmaceuticals Ltd.·interventional·Posted Dec 9, 2013·Updated Jul 8, 2019

In Brief

A Phase 3 clinical trial evaluating Apomorphine hydrochloride and Placebo for Parkinson's Disease. Completed, enrolled 107 participants across 20 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Denmark, France, Germany, Netherlands, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 9, 2013
Enrollment StartMar 3, 2014
Primary CompletionJun 6, 2016
Study CompletionJun 8, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.6 years ago

Interventions

Apomorphine hydrochloridedrug

Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe

Placebodrug

Sodium chloride 9 mg/ml