E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Parkinson's Disease |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety and tolerability of safinamide (50-100 mg p.o., q. d.) in PD patients. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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). |
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E.5.2.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 108 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Croatia |
Czech Republic |
Estonia |
Finland |
France |
Germany |
Hungary |
India |
Italy |
Korea, Republic of |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Peru |
Poland |
Portugal |
Romania |
Slovakia |
South Africa |
Spain |
Switzerland |
Taiwan |
Thailand |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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For administrative and safety reporting purposes the end of the trial will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all trial sites. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |