|
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:
|
2 August 2021 |
|
Main ID: |
EUCTR2004-000833-12-ES |
|
Date of registration:
|
23/11/2004 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.
|
|
Scientific title:
|
A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. |
|
Date of first enrolment:
|
02/12/2004 |
|
Target sample size:
|
250 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000833-12 |
|
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
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
|
|
|
Countries of recruitment
|
|
Italy
|
Spain
| | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Male or female, age 30-80 years, inclusive. If female, they must be either post-menopausal for at least 12 months, surgically sterilized or have undergone hysterectomy. Patients older than 80 years, who meet all other entry criteria, will be considered for enrollment, with approval of the Newron Medical Expert.
2. Diagnosis of idiopathic Parkinson’s disease of less than 5 years duration, with Hoehn and Yahr stage I-III.
3. Patients must have been receiving treatment with a single dopamine agonist at a stable dose for at least 4weeks prior to the screening visit. Patients will receive the study medication as add-on therapy starting at baseline.
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:
· The patient has any indication of forms of parkinsonism other than idiopathic Parkinson’s Disease.
· The patient is currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
· The patient has a concomitant disease likely to interfere with the study
· The patient has hypersensitivity or contraindications to MAO-B inhibitors.
· The patient has participated in a previous clinical trial within 30 days of entry into the study (screening visit) or has received treatment with any investigational compound within 30 days or 5 half-lives, whichever is longer, prior to screening.
· The patient has received treatment of his/her parkinsonian symptoms with a medication, other than a single dopamine agonist, during the 4 weeks preceding the screening visit.
· The patient has received treatment with opioids, SNRIs, tri- or tetra-cyclic antidepressants, MAO inhibitors (e.g. selegiline), meperidine derivatives, oral neuroleptics or any agent known to significantly inhibit or induce drug-metabolizing enzymes within 4 weeks prior to the screening visit.
· The patient has received a depot neuroleptic within one injection cycle.
· The patient has received treatment with a drug that has hepatotoxic potential, e.g., tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic potential, e.g, chemotherapy, within one year prior to the screening visit.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Early idiopathic Parkinson’s disease
MedDRA version: 7.0
Level: LLT
Classification code 10013113
|
|
Intervention(s)
|
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Safinamide
CAS Number: 202825-46-5
Current Sponsor code: NW-1015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Safinamide
CAS Number: 202825-46-5
Current Sponsor code: NW-1015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Safinamide
CAS Number: 202825-46-5
Current Sponsor code: NW-1015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Safinamide
CAS Number: 202825-46-5
Current Sponsor code: NW-1015
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
|
|
Primary Outcome(s)
|
Primary end point(s): 1. Change in mean value of UPDRS - Section III total score from baseline to endpoint.
2. CGI - Change from baseline to endpoint (proportion of patients showing improvement – scores of 1, 2 or 3).
|
|
Main Objective: The objectives of this study are to evaluate the safety and efficacy of two dose ranges of safinamide (50-100 and 150-200 mg/day, p.o.), compared to placebo, as add-on therapy in patients with early idiopathic Parkinson’s disease who are currently receiving a stable dose of a single dopamine agonist.
|
|
Secondary Objective:
|
|
Secondary ID(s)
|
|
NW-1015/015/III/2003
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 27/10/2004
Contact:
|
|