A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics

Conditions: Parkinson Disease
MedDRA version: 9.1Level: LLTClassification code 10013113

Registration Number: EUCTR2008-002769-30-IT

Lead Sponsor: MERCK SERONO SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures