PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS MedDRA version: 9.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Product Name: Safinamide
Product Code: NW-1015
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: T
Sponsors
NEWRON PHARMACEUTICALS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients are 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. Patients must have a diagnosis of idiopathic Parkinson?s disease of more than 5 years duration; the diagnosis should be based on medical history and neurological examination. Patients with a duration of Parkinson?s disease of at least 3 years, who meet all other entry criteria, will be considered for enrollment, with approval of the CRO Medical Monitor. 3. Patients must have a Hoehn and Yahr stage of I-IV during an ?off? phase. 4. Patients should be levodopa responsive and must have been receiving treatment with a stable dose of levodopa [4-10 doses per day of any levodopa preparation (including CR, IR or a combination of CR/IR), plus benserazide/carbidopa; with or without addition of a COMT inhibitor] and may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic at the screening visit. Patients will receive the study medication as add-on therapy starting at baseline. 5. Patients should have motor fluctuations, with >1.5 hours ?off? time during the day. 6. Patients must be able to maintain an accurate and complete diary (18-hour), with the help of a caregiver, recording ?on? time, ?on ? time with minor dyskinesia, ?on ? time with troublesome dyskinesia, ?off? time, and time asleep. 7. Patients must be able to understand and willing to sign an approved Informed Consent form. 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
Exclusion criteria: 1. The patient has any indication of forms of parkinsonism other than idiopathic Parkinson?s disease. 2. If female, the patient is of childbearing potential, pregnant or lactating. 3. The patient is in a late stage of Parkinson?s disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms. 4. The patient has a current diagnosis of substance abuse (DSM-IV) or history of alcohol or drug abuse in the past 3 months. 5. The patient has a 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, and Type I diabetes. Patients with a history of gastric ulcer who have not had an episode of acute gastritis in the last 6 months and are not currently experiencing gastric pain will be eligible for inclusion. 6. The patient has second- or third-degree atrio-ventricular 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 a significant ECG abnormality, including QTc >=450 msec (males) or >=470 msec (females), where QTc is based on Bazett?s correction method. 7. The patient has participated in a previous clinical trial with safinamide. 8. The patient has a concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug). 9. The patient has a history of psychosis, either previously or currently, or a score >=3 on Item 2 (thought disorder) or 3 (depression) of the UPDRS Section I. 10. The patient has evidence of dementia or cognitive dysfunction, as indicated by a MMSE score = 3 on item 1 (mentation) of the UPDRS, Section I. 11. The patient is depressed, as indicated by a GRID-HAMD (17-item scale) score > 17. 12. The patient has a history of allergic response to anticonvulsants, levodopa, or other anti-parkinsonian agents. 13. The patient has a mental or physical condition which would preclude performing efficacy or safety assessments. 14. The patient has hypersenstivity or contraindications to MAO B inhibitors. 15. The patient has a current history of severe dizziness or fainting on standing, due to postural hypotension. 16. The patient has a neoplastic disorder, which is either currently active or has been in remission for less than one year. 17. The patient has had stereotactic surgery as a treatment for his/her Parkinson?s disease. 18. 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 use of an investigational drug other than safinamide during the study is not permitted.19. The patient is receiving treatment of his/her depression with a MAO inhibitor, a tricyclic, or an SNRI at the screening visit. Note: Use of SSRIs will be permitted, provided the dose is kept as low as possible and remains stable throughout the trial. 20. The patient is receiving treatment of his/her parkinsonian symptoms with a MAO inhibitor. Note: Patients receiving amantadine, COMT inhibitors, DA agonists and/or anticholinergics will be eligible to enter the trial, p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Increase in mean daily ?on? time (?on? time without dyskinesia plus ?on? time with minor dyskinesia) during 18-hr diary recording period;Secondary Objective: Decrease in total daily ?off? time, as measured by diary cards decrease in mean ?off? time following first morning dose of levodopa change in cognition (cognitive test battery) improvement in the Dyskinesias Rating Scale during ?on? phase UPDRS Section II during ?on? phase (based on diary) - mean change from baseline to endpoint UPDRS Section III during ?on? phase (based on diary) - mean change from baseline to endpoint CGI - Change from baseline - mean score in the course of the study CGI - Severity of illness - mean change from baseline to endpoint mean percentage reduction in levodopa dose;Primary end point(s): Increase in mean daily ?on? time (?on? time without dyskinesia plus ?on? time with minor dyskinesia) during 18-hr diary recording period | — |
Countries
Italy
Outcome results
None listed