A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.

• Register: EUCTR
• Last refreshed on: 3 December 2012
• Main ID: EUCTR2007-002963-28-CZ
• Date of registration: 30/10/2007
• Prospective Registration: Yes
• Primary sponsor: Newron Pharmaceuticals SpA
• Public title: A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.
• Scientific title: A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of 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 IPD, as add-on to dopamine agonist
• Date of first enrolment: 19/01/2009
• Target sample size: 839
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-002963-28
• 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, 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:
1. Diagnosis of idiopathic Parkinson’s disease of less than 5 years duration, with a Hoehn and Yahr stage of I III. The diagnosis should be based on medical history and neurological examination.

2. Between the ages of 30 to 80 years, inclusive, at screening.

3. If female, be either post menopausal for at least 2 years, surgically sterilised or have undergone hysterectomy or, if of child bearing potential, be willing to avoid pregnancy by using an adequate method of contraception as defined in Section 6.4.10 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. Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit.

5. Willing and able to participate in the trial and have 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:
1. Any indication of forms of Parkinsonism, other than idiopathic Parkinson’s Disease.

2. If female, be pregnant or lactating.

3. Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.

4. Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.

5. Current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. (Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion).

6. Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or significant ECG abnormality, including QTc = 450 msec (males) or = 470 msec (females), where QTc is based on Bazett’s correction method.

7. Have received treatment with safinamide previously.

8. Concomitant disease likely to interfere with the trial medication (e.g. capable of altering absorption, metabolism or elimination of the trial drug).

9. History of, or current psychosis (e.g. schizophrenia or psychotic depression), or with a score = 3 on item 2 (thought disorder) or 3 (depression) of the UPDRS Section I at screening.

10. Evidence of dementia or cognitive dysfunction, as indicated by a MMSE score < 24, or a score = 3 on item 1 (mentation) of the UPDRS, Section I at screening.

11. Depression, as indicated by a GRID HAMD (17 item scale) score > 17 at screening.

12. History of allergic response to anticonvulsants or anti-Parkinsonian agents.

13. Mental or physical condition (e.g., neurotic behaviour, crippling degenerative arthritis, or limb amputation), which would preclude performing efficacy or safety assessments.

14. Hypersensitivity or contraindications to MAO B inhibitors.

15. Current history of severe dizziness or fainting on standing, due to postural hypotension.

16. Neoplastic disorder, which is either currently active or has been in remission for less than one year.

17. Participation in a clinical trial within 30 days of entry into the trial (screening visit) or has received treatment with any investigational compound within 30 days or 5 half lives, whichever is longer, prior to screening.

18. Treatment of their Parkinsonian symptoms with a medication, other than a stable dose of a single dopamine agonist, during the 8 weeks preceding the screening visit.

19. Treatment with any agent known to significantly inhibit or induce drug-metabolizing enyzmes (e.g., barbiturates, phenothiazines, etc.) within 4 weeks preceding the screening visit.

20. Treatment with opioids (e.g., tramadol, meperidine derivatives), SNRIs (e.g., venlafaxine, duloxetine), tri- or tetra-cyclic antidepressants, MAO inhibitors (e.g. selegiline), in the 8 weeks prior to the screening visit. Dextromethorphan will be permitted if used for treating cough.

21. Treatment with a depot neuroleptic within one injection cycle, or oral neuroleptics within 4 weeks prior to the screening visit.

22. Treatment with a drug that has hepatotoxic potential, e.g., tamoxifen,

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

Intervention(s)

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

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

Primary Outcome(s)

Main Objective: The objectives of this trial are to evaluate the safety and efficacy of two doses of safinamide (50 and 100 mg p.o. q.a.m.), compared to placebo, as add-on therapy in subjects with early idiopathic Parkinson’s Disease who are currently receiving a stable dose of a single dopamine agonist.

Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III).

Primary end point(s): UPDRS Section III score change from baseline to W24

Timepoint(s) of evaluation of this end point: Week 24

Secondary Objective: Evaluate the changes from baseline to W24 in activities of daily living, cognition, change in global clinical status, responder rates with regard to motor symptoms and health related quality of life

Secondary Outcome(s)

Secondary end point(s): - UPDRS Section II (ADL) score change from baseline to W24
- Cogtest® PD battery test score change from baseline to W24
- CGI - Severity scale score change from baseline to W24
- Proportion of subjects with scores 1,2,3 (showing improvement) on the
CGI change scale at W24
- CGI - Change scale score at W24
- Proportion of responders (subjects with at least 30% improvement on
the UPDRS – Section III score change from baseline to W24)
- EQ5D score change from baseline to W24
- PDQ-39 score change from baseline to W24

Timepoint(s) of evaluation of this end point: Week 24

Secondary ID(s)

2007-002963-28-FI

27918

Source(s) of Monetary Support

Merck Serono S.A. - Geneva

Newron Pharmaceuticals SpA