Status:
TERMINATED
Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients
Lead Sponsor:
Newron Pharmaceuticals SPA
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency ...
Eligibility Criteria
Inclusion
- the subject has completed a previous clinical study with Safinamide in PD
- the subject successfully completed all trial requirements of the antecedent trial
- if female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential, they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive
- subjects must be willing and able to participate in the trial and provide written informed consent
Exclusion
- the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide
- if female, the subject is pregnant or lactating
- any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
964 Patients enrolled
Trial Details
Trial ID
NCT00865579
Start Date
April 1 2009
End Date
June 1 2012
Last Update
September 18 2017
Active Locations (1)
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1
Research Site
Timuș, Romania