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

• 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

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
• Affiliation: Newron Pharmaceuticals SpA

• Name: Chief Medical Officer
• 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