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| Sponsored by: |
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
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2: Active Comparator
Safinimide 100mg/day
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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 |
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Serotonin Agonists Ropinirole Neurotransmitter Agents Hormone Antagonists Basal Ganglia Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Neurodegenerative Diseases Brain Diseases Dopamine Agonists Apomorphine Hormones Pramipexol Dopamine |
Movement Disorders Bromocriptine Ganglion Cysts Central Nervous System Diseases Cardiovascular Agents Serotonin Parkinson Disease Dopamine Agents Parkinsonian Disorders Lisuride Peripheral Nervous System Agents Cabergoline Pergolide |
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Serotonin Agonists Neurotransmitter Agents 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 Dopamine Agonists Neurodegenerative Diseases Brain Diseases 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 Peripheral Nervous System Agents Lisuride |