Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Rennes University Hospital
Enrollment:
192
Study Design:
This is a phase 3, randomized, parallel arm, interventional study designed to assess whether the use of apomorphine pump in relatively early motor fluctuation stage of PD positively impacts the social and occupational functioning of the PD participants, by improving their quality of life and delaying the appearance of severe disabling motor complications.
The study is including adults aged 65 years old or below with idiopathic PD with a disease duration of more than 4 years. They should have the presence of fluctuations and/or dyskinesia but for not more than 3 years. Participants must demonstrate impairment in activities of daily living or impairment of social and occupational functioning due to PD symptoms despite medical management. Standard exclusionary criteria apply. Participants with deep brain stimulation or lesional surgery or with LCIG are excluded. The study is currently recruiting across multiple centers in France.
The participants will be recruited over a period of 36 months and randomly assigned to one of the two arms to either receive apomorphine pump with an individually optimized dose or receive the best medical treatment, which could be the best single or combination therapy according to the guidelines of European Federation of Neurological Sciences. Participants will be followed for a year with clinical evaluations at months 6 and 12. The pump will be installed and adjusted at baseline during the first hospitalization and further pump adjustment and readjustment of oral medications are allowed every month. Additionally, there will be another 3-day hospitalization visit at month 3 for pump adjustment. The study will also collect data throughout the study for medico-economic evaluation.
Rationale:
The study kept the primary outcome as the change in the quality of life using the PDQ39 questionnaire from baseline to 12 months follow up. The secondary outcomes focus on the change in score over the course of 12 months from baseline and include various parameters including patient and neurologist’s global impression of change, MDS-UPDRS I-IV scales, non-motor symptoms scales, change in the best ON, ON with dyskinesia and OFF periods, adverse events. The secondary outcomes also explore changes in sleep, psychosocial functioning, depression, anxiety, and apathy scales.
Results:
Whether early initiation of infusion therapies can delay or alleviate the negative impact on PwP’s social and economic aspect of life is a critical question that remains unanswered. This study hopes to answer the question. Interestingly apomorphine has been shown to have an anti-dyskinetic effect and as such, will be interesting to find if early infusion delays the onset of the same.
