Parkinson Disease MedDRA version: 9.1 Level: LLT Classification code 10013113
Conditions
Interventions
Product Name: Safinamide
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Safinamide
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharm
Sponsors
MERCK SERONO SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gender: male or female 2. Age: ? 30 years 3. BMI: 18 - 32 kg/m2 4. Diagnosed with idiopathic Parkinson?s disease, with H&Y of I-III 5. Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa 6. ECG Normal 7. Negative beta-HCG test and not lactating (females). 8. Ability to maintain an accurate and complete dosing diary, with the help of a caregiver, recording doses of levodopa and study medication taken at home 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. Co-administration of other drugs causing dopamine release or affecting levodopa metabolism 2. Co-administration of other MAO inhibitors 3. The patient is in a late stage of Parkinson?s disease 4. Any indication of forms of Parkinsonism, other than idiopathic Parkinson?s disease. 5. Treatment with any agent known to inhibit or induce drug-metabolizing enzymes within 4 weeks prior study treatment 6. Concomitant oral iron treatment 7. History of hypersensitivity or contraindications to MAO-B inhibitors or levodopa 8. Clinically relevant allergies 9. Significant hepatic impairment 10. Significant renal impairment 11. Diseases or surgeries of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility 12. Diagnosis of HIV, or acute Hepatitis B or C 13. Clinically relevant disease 14. A neoplastic disorder, which is either currently active or has been in remission for less than one year. 15. Active psychiatric disease 16. History of melanoma 17. Signs for dementia 18. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of safinamide on the pharmacokinetics of levodopa, both after single and steady state dosing of safinamide;Secondary Objective: To assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen;Primary end point(s): Cmax and AUC0-6 of levodopa on Day 1 and Day 6 | — |
Countries
Italy
Outcome results
None listed