ARCADE is a Phase 2 open-label pilot study. A Phase 2 study typically evaluates different doses of a medicine that is in development. Open-label means the study participants know they will receive the investigational medicine. The term “pilot” indicates a primary step in the research process that will help determine if the study should be conducted in the same but larger manner in the future.
OV935 works in a new and different way, and it may be effective in controlling seizures. Four Phase I studies successfully evaluated healthy participants’ abilities to tolerate OV935. ARCADE is the first Phase 2 study of OV935 in children and adults with CDD or Dup15q. As with any clinical research study, all potential risks and benefits cannot be known in advance. Your child or the individual you care for will be closely monitored throughout the study so potential risks can be anticipated and addressed.
The medication is in pill form and is given twice a day during the trial.
To participate in the ARCADE study, individuals must meet the following criteria:
- Has a documented diagnosis of CDD or Dup15q
- Has a parent or caregiver who can provide consent and assent, attend scheduled visits and participate in study assessments
- Is between the ages of 2 and 35
- Has an average of at least three motor seizures per month
ARCADE also has other requirements that help ensure the safety of all participants. If your child or the individual you care for qualifies to participate in the study, these additional conditions will be reviewed with you by the team at your study medical center.
If you feel like this clinical trial might be right for your family, contact one of the study clinics below to schedule a screening.
Minnesota Epilepsy Group: Sarah Ellis
Phone: 651-241-5075; Email: firstname.lastname@example.org
Mass General Hospital: Rachelle Bookman
Phone: 617-643-4212; Email:email@example.com
Columbia: Wendy Chung
Phone 212-851-5313; Email: firstname.lastname@example.org
Center for Rare Disease (Atlanta): Ebun Dada
Phone: 617-984-9091; Email: email@example.com
UCLA: Fadiya Chowdhury
Phone: 310.206.3595; Email: FChowdhury@mednet.ucla.edu
Colorado: Janine Schenborn
Phone: (720) 777-4788; Email: Janine.firstname.lastname@example.org