Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder

Exclusion Criteria

• •1. Subjects with organic brain disease, for example, traumatic brain injury residua.
• •2. Subjects with a preexisting ophthalmologic condition.
• •3. Subjects with or at high risk of other types of irreversible vision loss or who require other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma.
• •4. Subjects meeting criteria for mental retardation as defined by the DSM-IV-TR.
• •5. Subjects with a history of seizure disorder (other than febrile seizure).
• •6. Subjects with history of Sydenham's Chorea.
• •7. Subjects with autism, schizophrenia, other psychotic disorder, or bipolar disorder.
• •8. Subjects with a primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment.
• •9. Subjects with a neurological disorder other than a tic disorder.
• •10. Subjects with a major medical illness.
• •11. Female subjects who are unwilling to use birth control or who are pregnant, as determined by serum pregnancy test at baseline assessment, or lactating.
• •12. Subjects who have a past or current history of substance dependence and/or a current history of substance abuse or who fail baseline toxicology screen.
• •13. Subjects who have any clinically significant abnormal laboratory result at baseline screening including EKG, or blood tests.
• •14. Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study.