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

Co-Principal Investigators: Barbara Coffey, MD, MS; Jonathan Brodie, MD, PhD

Sponsor: Catalyst

Overview: The purpose of this study is to investigate whether vigabatrin will reduce tics and to obtain systematic data regarding dosing, safety, and tolerability of vigabatrin in young adults with treatment refractory Tourette’s Disorder. Currently, the only formally approved treatments for TD are haloperidol and pimozide, typical neuroleptic agents known to have significant and unwanted side effects. Given the significant potential for such side effects, better-tolerated and efficacious alternatives are needed.

Inclusion Criteria

  • Age range: 12-65 years
  • Diagnosis of TD
  • Failure to respond to an adequate trial of clonidine, guanfacine, and a first generation (typical) and second generation (atypical) neuroleptic medication in the past
  • Tics are causing significant distress or impairment

Exclusion Criteria

  • Organic brain disease, e.g. traumatic brain injury residua
  • Preexisting ophthalmologic condition
  • High risk of other types of irreversible vision loss or use of other drugs associated with effects such as retinopathy or glaucoma
  • Diagnosis of mental retardation, autism, schizophrenia, other psychotic disorder, or bipolar disorder
  • History of seizure disorder (other than febrile seizure) or Sydenham's Chorea
  • Primary diagnosis of a major mood disorder that requires ongoing psychiatric treatment
  • Neurological disorder other than a tic disorder or a major medical illness
  • Past or current history of substance dependence
  • Female subjects unwilling to use birth control
  • Pregnancy or lactation

Based on this information, if you think that you or your child might be a good candidate for this study and would like to be contacted by the study team to find out more, please complete this form.