18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
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|ClinicalTrials.gov Identifier: NCT01286935|
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: Safinamide Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||544 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||August 2010|
|Experimental: Low Dose (50mg/day)||
|Experimental: High Dose (100mg/day)||
|Placebo Comparator: Placebo||
- Mean change in the dyskinesias rating scale (DRS) during "on" time [ Time Frame: Up to 104 weeks (from baseline 016 to EOS study 018) ]mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
- Endpoints include 'ON time', responder rates and UPDRS IV change [ Time Frame: Up to 104 weeks (from baseline 016 to EOS study 018) ]
- 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)
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|Ages Eligible for Study:||30 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286935
|Principal Investigator:||See Study 016 for details||PI's are the same as for study NW-1015/016/III/2006|
|Responsible Party:||Dr Ravi Anand (Chief Medical Officer), Newron Pharmaceuticals S.p.A.|
|Other Study ID Numbers:||
2006-005861-21 ( EudraCT Number )
|First Posted:||January 31, 2011 Key Record Dates|
|Last Update Posted:||January 31, 2011|
|Last Verified:||January 2011|
Patients with idiopathic Parkinson's Disease with motor fluctuations,
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases