Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1285

Inclusion Criteria

To be eligible for inclusion into this trial, subjects must fulfill all of the following criteria:
1.The subject has completed a previous clinical study with safinamide in PD, and;
2.The subject successfully completed all trial requirements of the antecedent trial, and;
3. For those patients for which this open label study is not yet available due to longer implementation of the study in the sites, the maximum time period off safinamide treatment is 12 months; NB: if the last visit of the antecedent study cannot be used as the baseline evaluation of the OL-study, a complete baseline examination must be performed.
4.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 childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive, and;
5.Subjects must be willing and able to participate in the trial and provide written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible for inclusion in this trial the subjects must not satisfy any of the following criteria:
1.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.
2.If female, the subject is pregnant or lactating.
3.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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of safinamide (50-100 mg p.o., q. d.) in PD patients.;Secondary Objective: To evaluate changes in dyskinesia and health economic parameters in subjects that entered directly from the SETTLE-study and to evaluate changes in the cognition by using the PD-CRS in subjects entered directly from Study EMR 701165-024 (the Cognition study).;Primary end point(s): The primary safety endpoints will include change from baseline on Dyskinesia Rating Scale (DRS) during the on phase (only applicable for patients coming from the SETTLE study (study number 27919)) physical and neurological examinations, vital signs, laboratory evaluations, electrocardiograms, AEs, UPDRS, dermatologic examinations, and ophthalmological examinations.;Timepoint(s) of evaluation of this end point: Up to 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints will include change from baseline in health economic variables (i.e., Health Resource Utilisation, EQ-5D, PDQ-39), and the PD-CRS in subjects entered directly from Study EMR 701165-024 (the Cognition study). ;Timepoint(s) of evaluation of this end point: One planned analysis will be conducted to analyze EQ-5D, PDQ-39 and HRU after all subjects enrolled from the SETTLE-study either complete 12 months or prematurely withdrew from study prior to 12 months in the Open-Label study. Additional analysis(ses) after the first analysis may be performed at any subsequent time prior to the final analysis

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