18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD

Study Overview
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Brief Summary
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The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.

Official Title
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A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Safinamide
* Drug: Safinamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population. The patient was compliant with taking study medication in Study 016. 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 016, and has reached Hoehn and Yahr Stage V. The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose (50mg/day)<br> | Drug: Safinamide<br> <br> |
| Experimental: High Dose (100mg/day)<br> | Drug: Safinamide<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the dyskinesias rating scale (DRS) during on time | mean change in the dyskinesias rating scale (DRS) during on time from baseline (study 016) to endpoint (last visit in study 018). | Up to 104 weeks (from baseline 016 to EOS study 018) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints include 'ON time', responder rates and UPDRS IV change | Chge in ON time (ON+ON minor dysk), Diary Resp Rate at 12-m, 18 & 24 m on the ITT&mITT pop&pts who completed 2-yr period UPDRS IV chge in total score,items 32-35 & 32-34 Time develop tblsome dysk(> 30min incr of tblsome dysk) Time develop any (minor &/or tblsome) dysk (> 30 min incr of dysk) Chge ADLs during ON, vs pbo(UPDRS II) Maintenance of effect in UPDRS II resp'(resp >=20% impr in ADLs). chge in L-dopa dose chge in any PD(other than L-dopa)drug dose Chge in UPDRS III, CGI-C and CGI-S Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP) | Up to 104 weeks (from baseline 016 to EOS study 018) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's Disease with motor fluctuations,