Recruiting
Phase 2

L-Dopa vs. Dopamine Agonists

Sponsor:

University of Toronto

Code:

NCT02347059

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

L-dopa

Dopamine Agonists (pramipexole, ropirinole)

Study Details

Brief summary:

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.

Conditions

Parkinson's Disease

Study ID

NCT02347059

Start date

Jan, 2015

Status verified date

Jan, 2015

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. patients with a clinical diagnosis of idiopathic PD according to the British Parkinson's Disease Society Brain Bank criteria
2. medical treatment with both L-dopa and DAs (either pramipexole or ropirinole) prior to surgery
3. 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
4. Informed consent to participate in the study

Exclusion Criteria:

  • History of active ICDs or depression (according to internal and international guidelines these patients are not deemed as surgical candidate)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

L-dopa

Antiparkinsonian medication

Dopamine Agonists (pramipexole, ropirinole)

Antiparkinsonian medication

Primary outcome measure

  • Severity at 3-month follow up visit after surgery of non-motor symptoms as assessed by the Non-motor Symptoms Scale (NMSS) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Alfonso Fasano, MD, PhD

+1416603500alfonso.fasano@gmail.com

Locations

Movement disorders Centre, Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Alfonso Fasano, MD, PhD

+1 416 603 5800alfonso.fasano@uhn.ca

More Information

Sponsor

University of Toronto

Last update posted

Jan 27, 2015

Last verified

Jan, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2015-01-27.