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| Sponsor: | EMD Serono |
|---|---|
| Information provided by (Responsible Party): | 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: Safinamide (as add-on therapy) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 679 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
50 mg/day Safinamide
|
Drug: Safinamide (as add-on therapy)
Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
Other Names:
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Active Comparator: 2
Safinamide 100mg/day
|
Drug: Safinamide (as add-on therapy)
Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Other Names:
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Placebo Comparator: 3
Placebo 0mg/Safinamide
|
Drug: Safinamide (as add-on therapy)
Safinamide add-on therapy with subjects with IPD treated with single dopamine agonist
Other Names:
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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
Show 125 Study Locations| Study Director: | Jonathan Willmer, MD | Merck Serono S.A., Geneva, an affiliate of Merck KGaA, Darmstadt, Germany |
More Information
| Responsible Party: | EMD Serono |
| ClinicalTrials.gov Identifier: | NCT00605683 History of Changes |
| Other Study ID Numbers: | 27918, 63,901, EudraCT: 2007-002963-28 |
| Study First Received: | December 19, 2007 |
| Last Updated: | January 27, 2012 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Bromocriptine Lisuride Pramipexol Cabergoline Pergolide Dopamine Agonists Dopamine |
Dopamine Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Cardiovascular Agents Sympathomimetics Autonomic Agents |