Apomorphine s.c. infusion in Parkinson's to control motor symptoms.
Research type
Research Study
Full title
Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO study.
IRAS ID
136240
Contact name
Sean Scott
Contact email
Sponsor organisation
STADA Arzneimittel AG
Eudract number
2013-000980-10
ISRCTN Number
N/A
Research summary
Patients with Parkinson’s disease suffer from muscle rigidity, resting tremor, postural instability and bradykinesia or kinesia. These motor symptoms result from a death of dopaminergic receptors. The transition from good motor function (ON state) to poor motor function (OFF State) occurs when brain L-dopa falls below a threshold. Apomorphine is a licenced compound which has been shown to have good effects on the ON-OFF phenomena.
This clinical trial will assess the effect of continuous subcutaneous infusions of Apomorphine hydrochloride in Parkinsons’ patients who do not have well controlled motor fluctuations compared to Parkinsons patients who are receiving placebo. Patients who are eligible for the study will have an initial dose finding (titration) whilst remaining in hospital for approximately 5 days. The dose titration will continue over a period of 4 weeks until the highest tolerated dose, to a maximum of 8mg/hour, is achieved. During the period of titration, patients will have other parkinsonian medications reduced or withdrawn, in a hierarchical order, under the supervision of their doctor. At the end of 4 weeks, patients will be on a stable dose of both trial medication and their other medications for the following 8 weeks of the double-blind phase of the study.
At the completion of 12 weeks, all patients will be offered apomorphine in an open label follow-up study for a further 9 months.Patients will be trained in the use of the infusion pump and skin care, to allow home-use either self-administered or with carer assistance. Infusions are anticipated to be between 14 – 16 hours per day.
The study will be conducted in a number of European countries, with a planned recruitment of 102 patients.
The study involves 14 visits, including the initial hospitalisation to commence treatment. Assessments will include patient completed diaries, quality of life questions and safety laboratory tests.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
13/NE/0327
Date of REC Opinion
21 Dec 2013
REC opinion
Further Information Favourable Opinion