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| Sponsor: | EMD Serono |
|---|---|
| Information provided by: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00605683 |
Purpose
Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man.
This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease.
The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Parkinson's Disease |
Drug: Safinimide (as add-on therapy) Drug: Safinimide (as add-on therapy) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | A Phase III, Double-Blind, Placebo-Controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as Add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist |
| Estimated Enrollment: | 666 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
50 mg/day Safinimide
|
Drug: Safinimide (as add-on therapy)
Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
|
|
2: Active Comparator
Safinimide 100mg/day
|
Drug: Safinimide (as add-on therapy)
Safinimide add-on therapy with subjects with IPD treated with single dopamine agonist
|
|
3: Placebo Comparator
Placebo 0mg/Safinimide
|
Drug: Safinimide (as add-on therapy)
Safinimide add-on therapy with subjects with IPD treated with single dopamine agonist
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
Contacts and Locations| Contact: Meritxell Raventos | 41 22 414 4614 | meritxell.raventos@merckserono.net |
| Brazil | |
| Research Site | Recruiting |
| Salvadore, Brazil | |
| Canada, Quebec | |
| Dynamik Research Inc. | Recruiting |
| Pointe-Claire, Quebec, Canada, H9R 3J1 | |
| Study Director: | Chris Kenney, MD | EMD Serono |
More Information
| Responsible Party: | Merck Serono SA - Geneva, an Affiliate of Merck KGaA, Darmstadt, Germany ( Meritxell Raventos, Clinical Project Manager ) |
| Study ID Numbers: | 27918, 63,901, EudraCT: 2007-002963-28 |
| Study First Received: | December 19, 2007 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00605683 History of Changes |
| Health Authority: | USA:FDA; Canada: Health Canada |
|
Serotonin Agonists Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cardiotonic Agents Anti-Dyskinesia Agents Hormone Antagonists Basal Ganglia Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiparkinson Agents Neurodegenerative Diseases Brain Diseases Dopamine Agonists |
Pramipexol Dopamine Movement Disorders Therapeutic Uses Bromocriptine Sympathomimetics Nervous System Diseases Central Nervous System Diseases Cardiovascular Agents Protective Agents Pharmacologic Actions Serotonin Agents Autonomic Agents Parkinson Disease Dopamine Agents |