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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 3 December 2012
Main ID:  EUCTR2008-004146-88-CZ
Date of registration: 07/04/2009
Prospective Registration: Yes
Primary sponsor: Newron Pharmaceuticals
Public title: An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonist
Scientific title: A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918
Date of first enrolment: 08/06/2009
Target sample size: 498
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-004146-88
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3  
Phase: 
Countries of recruitment
Argentina Brazil Bulgaria Canada Chile Colombia Croatia Czech Republic
Finland Germany India Italy Mexico Peru Poland Portugal
Slovakia South Africa Spain United States
Contacts
Name: Chief Medical Officer   
Address:  Ludovico Ariosto 21 20091 Bresso (Mi) Italy
Telephone: +39026103461
Email: ravi@anand.ch
Affiliation:  Newron Pharmaceuticals SpA
Name: Chief Medical Officer   
Address:  Ludovico Ariosto 21 20091 Bresso (Mi) Italy
Telephone: +39026103461
Email: ravi@anand.ch
Affiliation:  Newron Pharmaceuticals SpA
Key inclusion & exclusion criteria
Inclusion criteria:
To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria:
1. The subject completed 24 weeks of Trial 27918.
2. The subject successfully completed all trial requirements in Trial 27918.
3. 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 as defined in section 6.4.9 of the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes 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”.
4. Subject is willing and able to participate in the trial and has provided 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 meet any of the following criteria:
1. If female, the subject is pregnant or lactating.
2. The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator’s opionion.
3. The subject has shown clinically significant deterioration during participation in Trial 27918.
4. Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
5. The investigator deems it is not in the subject’s best interest to participate to trial 27938
6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Idiopathic Parkinson's Disease
MedDRA version: 14.1 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Primary end point(s): Time from baseline to first intervention, (change in the dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy).
Secondary Objective: The secondary objectives are to evaluate the changes from baseline to W78 in motor function, activities of daily living, global clinical status, health related quality of life and cognition with safinamide (50 and 100 mg/day) compared to placebo as add-on therapy to a single dopamine agonist.

The tertiary objectives are to evaluate the changes from baseline to W78 in depression, staging of disease, motor complications, cognition and Health Resource Utilization.
Main Objective: The primary objective is to evaluate the time to first intervention of two doses of safinamide (50 and 100 mg/day) compared to placebo as add-on therapy to a single dopamine agonist.
Timepoint(s) of evaluation of this end point: first intervention
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: Week 78
Secondary end point(s): • Proportion of subjects requiring intervention
• UPDRS Section III (motor) score change from baseline to W78
• UPDRS Section II (ADL) score change from baseline to W78
• CGI – Change scale score, change from Day 0 of Trial 27918 to W78
• CGI – Severity scale score change from baseline to W78
• EQ-5D score change from baseline to W78
• PDQ-39 score change from baseline to W78
• Cogtest® PD battery test score change from baseline to W78
Secondary ID(s)
2008-004146-88-FI
27938
Source(s) of Monetary Support
Newron Pharmaceuticals SpA
Merck Serono S.A. - Geneva
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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