Clinical trial NCT00605683 (phase 3, status: completed)
Conditions: idiopathic parkinson's disease
ICD codes: G20
Drugs: safinamide (as add-on therapy), safinamide (as add-on therapy), safinamide (as add-on therapy)
SMILES: C[C@H](NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O, C[C@H](NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O, C[C@H](NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O
Eligibility 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. 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 they must be willing to
             avoid pregnancy by using an adequate method of contraception for four weeks prior to,
             during and four weeks after the last dose of study medication. For the purposes of
             this study, 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 study and have provided written, informed
             consent.

        Exclusion Criteria:

        To be eligible for inclusion in this study the subjects must not meet any of the following
        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 study medication (e.g. capable of
             altering absorption, metabolism or elimination of the study drug).

          9. History of, or current psychosis (e.g. schizophrenia or psychotic depression) or 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-metabolising
             enzymes (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, within 4 weeks,
             or received radiation therapy or a drug with cytotoxic potential, e.g., chemotherapy,
             within one year prior to the screening visit.

         23. Diagnosis of HIV, or tests positive for Hepatitis C antibodies, or Hepatitis B surface
             antigen.

         24. Any abnormality that the investigator deems to be clinically relevant, either on
             medical history, physical examination, ECG or in a diagnostic laboratory test.

         25. 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.

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