Eligibility Requirements for the CTH-300/CTH-301 Trials

To potentially be eligible to participate in these trials, patients:

  • Must be 18 years of age or older (male or female)
  • Have a clinical diagnosis of idiopathic Parkinson’s disease
  • Have a clinically meaningful response to levodopa
  • Receive stable doses of levodopa/carbidopa (immediate or chronic release) administered at least four times per day OR Rytary™ administered three times per day, for at least four weeks before the initial screening visit; no planned medication changes or surgical interventions should be anticipated during the course of study
  • Must experience at least one well defined OFF episode per day with a total daily OFF time duration of at least two hours during the waking day, based on patient self-assessment
  • Must be stage III or less on the modified Hoehn and Yahr scale in the ON state
  • Must have a MMSE score over 25

Patients are not eligible for the trials if they have:

  • Atypical or secondary parkinsonism
  • Previous treatment with any of the following: a neurosurgical procedure for Parkinson’s disease; continuous subcutaneous apomorphine infusion; or Duodopa/Duopa
  • Treatment with any form of subcutaneous apomorphine within seven days prior to the initial screening visit. Patients that stopped subcutaneous apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered
  • Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite); Tigan® (trimethobenzamide hydrochloride; patients from U.S. sites only); or domperidone (patients from non-U.S. sites only)
  • Participated in a clinical trial within 30 days prior to the initial screening visit
  • Are currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents
  • Drug or alcohol dependency in the past 12 months
  • History of malignant melanoma
  • Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator
  • A major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult
  • A history of clinically significant hallucinations during the past six months
  • A history of clinically significant impulse control disorder(s)
  • Dementia that precludes providing informed consent or would interfere with participation in the study
  • Dementia that precludes providing informed consent or would interfere with participation in the study

For more detailed information about eligibility requirements, please visit ClinicalTrials.gov here and here.