Back to resultsSafinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Safinamide
Safinamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
- The patient was compliant with taking study medication in Study 015.
- The patient is willing to participate in the study and signed an approved Informed Consent form.
Exclusion Criteria:
- The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
- The patient has shown clinically significant deterioration during participation in Study 015.
- The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High Dose
Low dose
Placebo
Arm Description
150-200mg/day
50-100mg/day
Outcomes
Primary Outcome Measures
Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur
Secondary Outcome Measures
Full Information
NCT ID
NCT00642889
First Posted
March 21, 2008
Last Updated
March 21, 2008
Sponsor
Newron Pharmaceuticals SPA
1. Study Identification
Unique Protocol Identification Number
NCT00642889
Brief Title
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)
Official Title
A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Newron Pharmaceuticals SPA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.
Detailed Description
The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
227 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose
Arm Type
Experimental
Arm Description
150-200mg/day
Arm Title
Low dose
Arm Type
Experimental
Arm Description
50-100mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Safinamide
Intervention Type
Drug
Intervention Name(s)
Safinamide
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
The patient was compliant with taking study medication in Study 015.
The patient is willing to participate in the study and signed an approved Informed Consent form.
Exclusion Criteria:
The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
The patient has shown clinically significant deterioration during participation in Study 015.
The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.
12. IPD Sharing Statement
Learn more about this trial
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)
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