Clinical trial NCT01026428 (phase 1/phase 2, status: completed)
Conditions: idiopathic parkinson's disease
ICD codes: G20
Drugs: safinamide + levodopa
SMILES: C[C@H](NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O
Eligibility criteria:

        Inclusion Criteria:

          1. Gender: male or female

          2. Age: 30 years

          3. Body Mass Index (BMI): 18 - 32 kg/m2

          4. Diagnosed with idiopathic Parkinson's disease, with Hoehn and Yahr (H&Y) of I-III

          5. Levodopa-responsive patients treated with a stable dose of levodopa/carbidopa

          6. Electrocardiogram recording (12 leads) normal or with abnormalities which are not
             hazardous to the patient according to the opinion of the investigator.

          7. Negative beta-HCG test and not lactating (females). Women who are of childbearing
             potential must be using acceptable methods of contraception and should be informed of
             the potential risks associated with becoming pregnant while enrolled within a clinical
             research study. Accepted forms of contraception are: i.e. intrauterine device and a
             barrier method, combined oral contraceptives and a barrier method, or double-barrier
             method throughout the study. Female volunteers who are post -menopausal or surgically
             sterile may be enrolled

          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 All
             parameters will be determined within three weeks prior to first dosing. Subjects must
             have given written informed consent before any study-related activities are carried
             out

        Exclusion Criteria:

        To be eligible for inclusion in this study the subjects must not meet any of the following
        criteria:

          1. Co-administration of other drugs causing dopamine release (e.g. reserpine) or
             affecting levodopa metabolism (e.g COMT inhibitors except AADC inhibitors) or any
             other medication clinically contraindicated with MAO B inhibitors or with
             levodopa/carbidopa Note: Use of Selective serotonin reuptake inhibitors [SSRI] and
             selective noradrenalin reuptake inhibitors [SNRI] will be permitted, provided the dose
             is kept as low as possible and remains stable throughout the trial.

          2. Co-administration of other MAO inhibitors (e.g. selegiline, rasagiline)

          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. 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 (e.g.,
             barbiturates, St John's Wort etc.) 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 (especially hypersensitivity toward any medicinal drugs)

          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 Human Immunodeficiency Virus (HIV), or acute Hepatitis B or C

         13. Clinically relevant disease which in the investigator's opinion would exclude the
             subject from the study, such as significant cardiovascular and lung diseases,
             narrow-angle glaucoma or endocrinological diseases such as hyperthyroidism or
             pheochromocytoma

         14. A neoplastic disorder, which is either currently active or has been in remission for
             less than one year.

         15. Active psychiatric disease (e.g, schizophrenia, psychotic depression)

         16. History of melanoma or current cancer disease and undiagnosed, but melanoma suspicious
             skin lesion

         17. Signs for dementia which could interfere with the compliance to the study as judged by
             the investigator

         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 (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any
             cause, any active retinopathy or ocular inflammation (uveitis), or diabetic
             retinopathy.

         19. Consumption of important quantities of coffee or tea corresponding to more than 600 mg
             caffeine/day, or tobacco smoking (more than 10 cigarettes per day)

         20. Diet considerably deviating from normal nutritional patterns (e.g. vegan; diets with
             very high protein content [Atkins])

         21. Participation in another clinical study within 30 days prior to the planned first drug
             administration

         22. Alcohol and drug abuse (during the past three years)

         23. Transfusion of blood or plasma derivatives within 3 month prior to the planned first
             drug administration

         24. Blood donation within 90 days before the start of the clinical study

         25. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family
             members who suffer(ed) from such.