Main
|
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: |
|
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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|