Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects
Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease Subjects
Approximately twenty four (24) subjects will participate in this research trial. The research
 trial will be conducted in approximately twelve (12) medical centers in the following
 countries: Germany, France, South Africa, Austria and Canada. The research trial will last
 until December 2011.
Inclusion Criteria:

 1. The subject has given his/her written informed consent to participate in the trial.

 2. The subject presents with a diagnosis of idiopathic Parkinson's disease according to
 the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnosis
 Criteria

 3. The subject is an out-patient aged 30 years or above.

 4. PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state).

 5. PD subjects experiencing levodopa induced dyskinesias, specifically predictable
 peak-dose dyskinesia.

 6. Peak-dose dyskinesia must be considered by the subject to be problematic and/or
 disabling.

 7. Peak-dose dyskinesia must warrant medical treatment in the Investigator's opinion.

 8. The subject has participated successfully in a diary-card training session.

 9. In the judgment of the Investigator based on the subject's history, previous
 treatments, and the clinical presentation, the subject is considered as being
 optimally treated at screening (i.e., further adjustments of current medication will
 not further improve the subject's symptoms of Parkinson's disease).

 10. Stable dose of PD drugs for at least 4 weeks before Screening Visit. This may include:
 levodopa dopamine agonists, c-ortho methyl transferase (COMT) inhibitors, and
 anticholinergics.

 11. The dose of levodopa and all PD drugs used during the trial must remain unchanged
 throughout the trial.

 12. Female subjects must be neither pregnant or breast-feeding and must lack child-bearing
 potential, as defined either by:

 1. be either post menopausal for at least 2 years , surgically sterilised or have
 undergone hysterectomy, or

 2. if of child bearing potential, 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 trial medication. For the purposes of this trial, 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.

 13. The subject shows adequate compliance with the schedule for intake of trial medication
 and the completion of the diaries.

 Exclusion Criteria:

 1. The subject has participated in any safinamide clinical trial before.

 2. The subject is experiencing exclusively diphasic, off state, myoclonic, dystonic, or
 akathetic dyskinesias without peak dose dyskinesia.

 3. (For female subjects) The subject is pregnant or lactating.

 4. Treatment with a MAO-B inhibitor within the eight weeks prior to the screening visit.

 5. Treatment with amantadine in the four weeks prior to the screening visit or budipine
 in the eight weeks prior to the screening visit.

 6. Treatment with opioids (e.g., tramadol, meperidine derivatives), serotonin
 norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine, duloxetine), tri- or
 tetra-cyclic antidepressants, in the past 8 weeks prior to the screening visit.
 Dextromethorphan will be permitted if used for treating cough.

 7. The subject has received neurosurgical intervention related to PD (e.g. deep brain
 stimulation, thalamotomy etc.) or is scheduled to do so during the trial period.

 8. Current clinically significant gastro-intestinal, renal, hepatic, endocrine, pulmonary
 or cardiovascular disease, including acute gastric ulcer, hypertension that is not
 well controlled, asthma, chronic obstructive pulmonary disease (COPD), and unstable
 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.

 9. Neoplastic disorder, which is either currently active or has been in remission for
 less than one year.

 10. Diagnosis of HIV, or positive test for Hepatitis C antibodies, or Hepatitis B surface
 antigen.

 11. Concomitant disease likely to interfere with trial medication (e.g. capable of
 altering absorption, metabolism, or elimination of the trial drug).

 12. The subject has any clinically significant illness that, in the Investigator's
 opinion, might interfere with the subject's ability to participate in the trial.

 13. 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 corrected QT interval (QTc) - 450 msec (males) or - 470 msec (females),
 where QTc is based on Bazett's correction method.

 14. 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

 15. The subject is suffering from any dementia or other psychiatric illness that prevents
 him/her from giving informed consent, i.e. Montreal Cognitive Assessment (MoCA) <23
 points.

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

 17. Known hypersensitivity to the trial treatment(s), including placebo or other
 comparator drug(s).

 18. The subject has legal incapacity or limited legal capacity.

 19. The subject is participating in another clinical trial or has done so within the past
 30 days

 20. 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.

 21. Subjects with current diagnosis of substance abuse (DSM-IV) or history of alcohol or
 drug abuse in the past three months.