A Randomized, Single-blind Trial on the Efficacy and Safety of L-dopa Monotherapy Versus Dopamine Agonists Monotherapy After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

Who is this study for? Patients with Parkinson's disease
What treatments are being studied? L-dopa
Status: Unknown status
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2

Deep Brain Stimulation (DBS) of the Subthalamic nucleus (STN) is an established treatment for patients with advanced Parkinson's disease (PD). STN DBS improves dopaminergic drug-responsive motor symptoms, thus allowing a reduction of post-operative drug dose. However, a considerable variation in the extent of dopaminergic drug reduction has been reported, with values ranging from 20% to 100%. Both L-dopa and DAs can be used, however, there are no formal studies examining which type of antiparkinsonian medication may be more effective and/or better tolerated following STN DBS. Aim of our study is to compare the efficacy and the tolerability of L-dopa monotherapy versus DAs monotherapy after STN DBS over a 3-month follow up period. This study is a prospective, single blind parallel trial comparing L-dopa monotherapy and DAs monotherapy after STN DBS. Patients will be enrolled in pairs, with one patient randomly assigned to L-dopa monotherapy and the other to DA monotherapy after STN DBS (20 patients for each study arm). Treatment assignment will be unmasked for the patient but will be blinded for the neurologist programming DBS and evaluating the patient. Another neurologist will be in charge of medication adjustments. Primary outcome is the change in severity of non-motor symptoms as assessed by the Non-motor Symptoms Scale (NMSS) at 3-month follow up visit after surgery. In spite of an improvement of the motor condition many patients develop apathy and depression following surgery (Neurosurgery in Parkinson's disease: the doctor is happy, the patient less so). This study will shed light on the best way to manage patients after STN procedure, thus contributing to a further improvement of the surgical outcome in a population of young and motivated patients (those commonly receiving STN DBS), eventually bringing them closer to a normal personal and social life. Results of our study may provide new insights in the management of advanced PD after STN DBS, further leading to development of future larger trials.

Participation Requirements
Sex: All
Healthy Volunteers: No

• patients with a clinical diagnosis of idiopathic PD according to the British Parkinson's Disease Society Brain Bank criteria

• medical treatment with both L-dopa and DAs (either pramipexole or ropirinole) prior to surgery

• candidacy for STN DBS according to the treating physician and fulfillment of the inclusion and exclusion criteria proposed by the core assessment program for surgical interventional therapies in Parkinson's disease panel

• Informed consent to participate in the study

Other Locations
Movement disorders Centre, Toronto Western Hospital
Contact Information
Alfonso Fasano, MD, PhD
Time Frame
Start Date: January 2015
Completion Date: August 2016
Target number of participants: 40
Experimental: L-dopa
L-dopa will be administered as monotherapy. The dosage and the frequency of intakes are not pre-specified and will be individualized.
Active Comparator: Dopamine agonist
Dopamine agonists (either pramipexole or ropirinole) will be administered as monotherapy. The dosage and the frequency of intakes are not pre-specified and will be individualized.
Leads: University of Toronto
Collaborators: Michael J. Fox Foundation for Parkinson's Research

This content was sourced from clinicaltrials.gov

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