Conditions: Parkinson's Disease
Keywords: Parkinson's disease motor fluctuations not well controlled medical treatment apomorphine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief 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

Arms:
arm 1: Apo-go® Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe arm 2: Placebo: saline infusion

Interventions: intervention 1: Apomorphine hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe intervention 2: Sodium chloride 9 mg/ml

Protocol document: