L-dopa Versus Dopamine Agonists After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease

NCT02347059 | Unknown Phase 2

• 1 other identifier: 14-8303
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (8)

• activities of daily living as assessed by the MDS Unified Parkinson's Disease Rating Scale, Activities of daily living section (MDS-UPDRS-II)

  3 months

• • the severity of motor symptoms, as assessed by the MDS Unified Parkinson's Disease Rating Scale, motor section (MDS-UPDRS-III)

  3 months

• • motor fluctuations and dyskinesias as assessed by the MDS Unified Parkinson's Disease Rating Scale, part IV (MDS- UPDRS-IV)

  3 months

• • the quality of life, as assessed by the Parkinson's Disease Questionnaire (PDQ-39) summary index

  3 months

• • prevalence and severity of depression and apathy as assessed by the Hospital Anxiety Depression Scale (HADS) and the Apathy Evaluation Scale (AES, both self- and informant-rating scales)

  3 months

Study Arms (2)

L-dopa

EXPERIMENTAL

L-dopa will be administered as monotherapy. The dosage and the frequency of intakes are not pre-specified and will be individualized.

Drug: L-dopa

Dopamine agonist

ACTIVE COMPARATOR

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.

Drug: Dopamine Agonists (pramipexole, ropirinole)

Interventions

L-dopa DRUG

Antiparkinsonian medication

Also known as: Levodopa

L-dopa

Dopamine Agonists (pramipexole, ropirinole) DRUG

Antiparkinsonian medication

Also known as: Pramipexole, Ropirinole

Dopamine agonist

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Informed consent to participate in the study
• History of active ICDs or depression (according to internal and international guidelines these patients are not deemed as surgical candidate)

Sponsors & Collaborators

• University of Toronto: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Movement disorders Centre, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Dopamine Agonists; Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Alfonso Fasano, MD, PhD

  Movement Disorders Centre Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Fasano, MD, PhD

CONTACT

+1416603500; alfonso.fasano@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Movement Disorders centre

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

CA (1)